[ { "_id": "440234753", "fda_orphan_drug": [ { "pubchem_sid": 440234753, "generic_name": "apadamtase alfa", "designated_date": "2020-09-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Baxalta US Inc.|300 Shire Way|Lexington|Massachusetts|2421|United States", "orphan_designation": { "original_text": "Treatment of Sickle Cell Disease", "umls": "C0002895", "parsed_text": "Sickle Cell Disease" } } ] }, { "_id": "404772603", "fda_orphan_drug": [ { "pubchem_sid": 404772603, "generic_name": "apadamtase alfa", "designated_date": "2020-09-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Baxalta US Inc.|300 Shire Way|Lexington|Massachusetts|2421|United States", "orphan_designation": { "original_text": "Treatment of Sickle Cell Disease", "umls": "C0002895", "parsed_text": "Sickle Cell Disease" } } ] }, { "_id": "381128258", "fda_orphan_drug": [ { "pubchem_sid": 381128258, "generic_name": "apadamtase alfa", "designated_date": "2020-09-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Baxalta US Inc.|300 Shire Way|Lexington|Massachusetts|2421|United States", "orphan_designation": { "original_text": "Treatment of Sickle Cell Disease", "umls": "C0002895", "parsed_text": "Sickle Cell Disease" } } ] }, { "_id": "405023558", "fda_orphan_drug": [ { "pubchem_sid": 405023558, "generic_name": "1-118-signal regulatory protein alpha (human) fusion protein with immunoglobulin G1 (human Fc fragment), dimer", "designated_date": "2018-03-08", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Trillium Therapeutics Inc.|2488 Dunwin Drive|Mississauga|Canada", "orphan_designation": { "original_text": "Treatment of Cutaneous T-Cell Lymphoma", "umls": "C0079773", "parsed_text": "cutaneous T-cell lymphoma" } } ] }, { "_id": "332853708", "fda_orphan_drug": [ { "pubchem_sid": 332853708, "generic_name": "2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione", "designated_date": "2010-09-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "GenKyoTex S.A.|14 Chemin des Aulx|Geneva|Switzerland", "orphan_designation": { "original_text": "Treatment of idiopathic pulmonary fibrosis.", "umls": "C1800706", "parsed_text": "Idiopathic Pulmonary Fibrosis" } } ] }, { "_id": "319393237", "fda_orphan_drug": [ { "pubchem_sid": 319393237, "generic_name": "2-hydroxymethyl-2-methoxymethyl-1-azabicyclo[2,2,2]octan-3-one", "designated_date": "2019-04-11", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Aprea Therapeutics AB|Nobels Vag 3|Solna,|Sweden", "orphan_designation": { "original_text": "Treatment of Myelodysplastic Syndrome", "umls": "C3463824", "parsed_text": "MYELODYSPLASTIC SYNDROME" } } ] }, { "_id": "369038179", "fda_orphan_drug": [ { "pubchem_sid": 369038179, "generic_name": "2-hydroxypropyl-B-cyclodextrin", "designated_date": "2013-02-18", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Vtesse, Inc.|700 Technology Square|Third Floor|Cambridge|Massachusetts|2139|United States", "orphan_designation": { "original_text": "Treatment of Niemann Pick disease, type C.", "umls": "C0220756", "parsed_text": [ "Niemann Pick Disease", "Type C" ] } } ] }, { "_id": "255374991", "fda_orphan_drug": [ { "pubchem_sid": 255374991, "generic_name": "2-hydroxypropyl-B-cyclodextrin", "designated_date": "2013-02-18", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Vtesse, Inc.|700 Technology Square|Third Floor|Cambridge|Massachusetts|2139|United States", "orphan_designation": { "original_text": "Treatment of Niemann Pick disease, type C.", "umls": "C0220756", "parsed_text": [ "Niemann Pick Disease", "Type C" ] } } ] }, { "_id": "254764800", "fda_orphan_drug": [ { "pubchem_sid": 254764800, "generic_name": "2-hydroxypropyl-B-cyclodextrin", "designated_date": "2013-02-18", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Vtesse, Inc.|700 Technology Square|Third Floor|Cambridge|Massachusetts|2139|United States", "orphan_designation": { "original_text": "Treatment of Niemann Pick disease, type C.", "umls": "C0220756", "parsed_text": [ "Niemann Pick Disease", "Type C" ] } } ] }, { "_id": "404772496", "fda_orphan_drug": [ { "pubchem_sid": 404772496, "generic_name": "225Ac-lintuzumab", "designated_date": "2014-11-25", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Actinium Pharmaceuticals, Inc.|379 Thornall Avenue|6th Floor|Edison|New Jersey|8837|United States", "orphan_designation": { "original_text": "Treatment of acute myelogenous leukemia", "umls": "C0023467", "parsed_text": "Acute myelogenous leukemia" } } ] }, { "_id": "402426007", "fda_orphan_drug": [ { "pubchem_sid": 402426007, "generic_name": "225Ac-lintuzumab", "designated_date": "2014-11-25", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Actinium Pharmaceuticals, Inc.|379 Thornall Avenue|6th Floor|Edison|New Jersey|8837|United States", "orphan_designation": { "original_text": "Treatment of acute myelogenous leukemia", "umls": "C0023467", "parsed_text": "Acute myelogenous leukemia" } } ] }, { "_id": "223844000", "fda_orphan_drug": [ { "pubchem_sid": 223844000, "generic_name": "4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl", "designated_date": "2015-09-29", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Recursion Pharmaceuticals, LLC|383 S. Colorow Drive|Salt Lake City|Utah|84108|United States", "orphan_designation": { "original_text": "Treatment of cerebral cavernous malformation.", "umls": "C2919945", "parsed_text": "Cerebral Cavernous Malformation" } } ] }, { "_id": "117651832", "fda_orphan_drug": [ { "pubchem_sid": 117651832, "generic_name": "4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl", "designated_date": "2015-09-29", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Recursion Pharmaceuticals, LLC|383 S. Colorow Drive|Salt Lake City|Utah|84108|United States", "orphan_designation": { "original_text": "Treatment of cerebral cavernous malformation.", "umls": "C2919945", "parsed_text": "Cerebral Cavernous Malformation" } } ] }, { "_id": "53789268", "fda_orphan_drug": [ { "pubchem_sid": 53789268, "generic_name": "4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl", "designated_date": "2015-09-29", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Recursion Pharmaceuticals, LLC|383 S. Colorow Drive|Salt Lake City|Utah|84108|United States", "orphan_designation": { "original_text": "Treatment of cerebral cavernous malformation.", "umls": "C2919945", "parsed_text": "Cerebral Cavernous Malformation" } } ] }, { "_id": "319393478", "fda_orphan_drug": [ { "pubchem_sid": 319393478, "generic_name": "4-{[(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid", "designated_date": "2014-05-19", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Roche Genentech|F. Hoffmann-La Roche Ltd.|430 East 29th Street|New York|New York|10016|United States", "orphan_designation": { "original_text": "Treatment of Acute Myeloid Leukemia", "umls": "C0023467", "parsed_text": "Acute myeloid leukemia" } } ] }, { "_id": "160687627", "fda_orphan_drug": [ { "pubchem_sid": 160687627, "generic_name": "90Y-hPAMA4", "designated_date": "2004-01-29", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Immunomedics, Inc.|300 American Road|Morris Plains|New Jersey|7950|United States", "orphan_designation": { "original_text": "Treatment of pancreatic cancer", "umls": "C0235974", "parsed_text": "PANCREATIC CANCER" } } ] }, { "_id": "404719631", "fda_orphan_drug": [ { "pubchem_sid": 404719631, "generic_name": "A-dmDT390-bisFv(UCHT1)", "designated_date": "2014-10-09", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Angimmune, LLC|American Red Cross Holland Laboratory|15601 Crabbs Branch Way|Rockville|Maryland|20855|United States", "orphan_designation": { "original_text": "Treatment of cutaneous T-cell lymphoma", "umls": "C0079773", "parsed_text": "cutaneous T-cell lymphoma" } } ] }, { "_id": "255366256", "fda_orphan_drug": [ { "pubchem_sid": 255366256, "generic_name": "abagovomab", "designated_date": "2003-11-25", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Menarini Ricerche S.p.A.|Via Tito Speri 10|Pomezia|Roma|Italy", "orphan_designation": { "original_text": "Treatment of epithelial ovarian cancer", "umls": "C4721610", "parsed_text": "Epithelial Ovarian Cancer" } } ] }, { "_id": "252166477", "fda_orphan_drug": [ { "pubchem_sid": 252166477, "generic_name": "abagovomab", "designated_date": "2003-11-25", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Menarini Ricerche S.p.A.|Via Tito Speri 10|Pomezia|Roma|Italy", "orphan_designation": { "original_text": "Treatment of epithelial ovarian cancer", "umls": "C4721610", "parsed_text": "Epithelial Ovarian Cancer" } } ] }, { "_id": "160693407", "fda_orphan_drug": [ { "pubchem_sid": 160693407, "generic_name": "abagovomab", "designated_date": "2003-11-25", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Menarini Ricerche S.p.A.|Via Tito Speri 10|Pomezia|Roma|Italy", "orphan_designation": { "original_text": "Treatment of epithelial ovarian cancer", "umls": "C4721610", "parsed_text": "Epithelial Ovarian Cancer" } } ] }, { "_id": "135318753", "fda_orphan_drug": [ { "pubchem_sid": 135318753, "generic_name": "abagovomab", "designated_date": "2003-11-25", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Menarini Ricerche S.p.A.|Via Tito Speri 10|Pomezia|Roma|Italy", "orphan_designation": { "original_text": "Treatment of epithelial ovarian cancer", "umls": "C4721610", "parsed_text": "Epithelial Ovarian Cancer" } } ] }, { "_id": "441072535", "fda_orphan_drug": [ { "pubchem_sid": 441072535, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 441072535, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 441072535, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 441072535, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "440790639", "fda_orphan_drug": [ { "pubchem_sid": 440790639, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 440790639, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 440790639, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 440790639, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "386474197", "fda_orphan_drug": [ { "pubchem_sid": 386474197, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 386474197, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 386474197, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 386474197, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "386467149", "fda_orphan_drug": [ { "pubchem_sid": 386467149, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 386467149, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 386467149, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 386467149, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "178103473", "fda_orphan_drug": [ { "pubchem_sid": 178103473, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 178103473, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 178103473, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 178103473, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "135355129", "fda_orphan_drug": [ { "pubchem_sid": 135355129, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 135355129, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 135355129, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 135355129, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "103771521", "fda_orphan_drug": [ { "pubchem_sid": 103771521, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 103771521, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 103771521, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 103771521, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "50070209", "fda_orphan_drug": [ { "pubchem_sid": 50070209, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 50070209, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 50070209, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 50070209, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "46509198", "fda_orphan_drug": [ { "pubchem_sid": 46509198, "generic_name": "abatacept", "designated_date": "2013-05-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Orban Biotech LLC|64 Aspinwall Avenue|Brookline|Massachusetts|2446|United States", "orphan_designation": { "original_text": "Treatment of type 1 diabetes mellitus patients with residual beta cell function", "umls": "C0011854", "parsed_text": "Type 1 diabetes mellitus" } }, { "pubchem_sid": 46509198, "generic_name": "abatacept", "designated_date": "2017-12-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Co.|P. O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prevention of Graft versus Host Disease", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 46509198, "generic_name": "Abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of giant cell arteritis", "umls": "C0039483", "parsed_text": "Giant Cell Arteritis" } }, { "pubchem_sid": 46509198, "generic_name": "abatacept", "designated_date": "2017-02-22", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Bristol-Myers Squibb Research & Development|Marketed Products Development - Regulatory Strategy|P.O. Box 5326|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Treatment of idiopathic inflammatory myopathy (IIM)", "umls": [ "C0751356", "C3888318" ], "parsed_text": [ "idiopathic inflammatory myopathy", "IIM" ] } } ] }, { "_id": "404770371", "fda_orphan_drug": [ { "pubchem_sid": 404770371, "generic_name": "Abetimus", "designated_date": "2000-07-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "La Jolla Pharmaceutical Co.|6455 Nancy Ridge Dr.|San Diego|California|92121|United States", "orphan_designation": { "original_text": "Treatment of lupus nephritis.", "umls": "C0024143", "parsed_text": "Lupus Nephritis" } } ] }, { "_id": "160687556", "fda_orphan_drug": [ { "pubchem_sid": 160687556, "generic_name": "Abetimus", "designated_date": "2000-07-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "La Jolla Pharmaceutical Co.|6455 Nancy Ridge Dr.|San Diego|California|92121|United States", "orphan_designation": { "original_text": "Treatment of lupus nephritis.", "umls": "C0024143", "parsed_text": "Lupus Nephritis" } } ] }, { "_id": "135325229", "fda_orphan_drug": [ { "pubchem_sid": 135325229, "generic_name": "Abetimus", "designated_date": "2000-07-28", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "La Jolla Pharmaceutical Co.|6455 Nancy Ridge Dr.|San Diego|California|92121|United States", "orphan_designation": { "original_text": "Treatment of lupus nephritis.", "umls": "C0024143", "parsed_text": "Lupus Nephritis" } } ] }, { "_id": "441072525", "fda_orphan_drug": [ { "pubchem_sid": 441072525, "generic_name": "adalimumab", "trade_name": "Humira", "designated_date": "2005-03-21", "designation_status": "Designated/Approved", "approved_labeled_indication": "Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.", "marketing_approval_date": "2014-09-30", "exclusivity_end_date": "2021-09-30", "exclusivity_protected_indication": "Treatment of polyarticular juvenile idiopathic arthritis in patients 2 to less than 4 years of age.", "sponsor": "AbbVie Inc.|1 North Waukegan Road|Bldg. 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Approved for Orphan Indication", "sponsor": "Biogen, Inc.|225 Binney Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of Progressive Supranuclear Palsy", "umls": "C0038868", "parsed_text": "Progressive supranuclear palsy" } } ] }, { "_id": "404719773", "fda_orphan_drug": [ { "pubchem_sid": 404719773, "generic_name": "anti-inhibitor coagulant complex", "trade_name": "FEIBA", "designated_date": "2013-04-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors", "marketing_approval_date": "2013-12-16", "exclusivity_end_date": "2020-12-16", "exclusivity_protected_indication": "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors", "sponsor": "Baxalta US, Inc.|One Baxter Way|West Lake Village|California|91362|United States", "orphan_designation": { "original_text": "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors", "umls": "C0019069", "parsed_text": "Hemophilia A" } } ] }, { "_id": "347911435", "fda_orphan_drug": [ { "pubchem_sid": 347911435, "generic_name": "anti-inhibitor coagulant complex", "trade_name": "FEIBA", "designated_date": "2013-04-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors", "marketing_approval_date": "2013-12-16", "exclusivity_end_date": "2020-12-16", "exclusivity_protected_indication": "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors", "sponsor": "Baxalta US, Inc.|One Baxter Way|West Lake Village|California|91362|United States", "orphan_designation": { "original_text": 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of bleeding episodes in hemophilia A and B patients with inhibitors", "umls": "C0019069", "parsed_text": "Hemophilia A" } } ] }, { "_id": "46506920", "fda_orphan_drug": [ { "pubchem_sid": 46506920, "generic_name": "anti-T-lymphocyte immune globulin, rabbit", "designated_date": "2010-03-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Neovii Biotech NA, Inc.|6 Liberty Square|PMB #295|Boston|Massachusetts|2109|United States", "orphan_designation": { "original_text": "Prevention of graft versus host disease (GVHD)", "umls": "C0018133", "parsed_text": "GRAFT VERSUS HOST DISEASE" } }, { "pubchem_sid": 46506920, "generic_name": "anti-T-lymphocyte immune globulin, rabbit", "designated_date": "2008-09-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Neovii Biotech NA, Inc.|6 Liberty Square|PMB #295|Boston|Massachusetts|2109|United States", "orphan_designation": { "original_text": "Prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation", "umls": "C1735634", "parsed_text": "Acute allograft rejection" } }, { "pubchem_sid": 46506920, "generic_name": "anti-thymocyte Globulin (rabbit)", "designated_date": "2000-09-06", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Genzyme Corporation|A Sanofi Company|500 Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of myelodysplastic syndrome", "umls": "C3463824", "parsed_text": "MYELODYSPLASTIC SYNDROME" } } ] }, { "_id": "134223943", "fda_orphan_drug": [ { "pubchem_sid": 134223943, "generic_name": "anti-thymocyte Globulin (rabbit)", "designated_date": "2000-09-06", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Genzyme Corporation|A Sanofi Company|500 Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of myelodysplastic syndrome", "umls": "C3463824", "parsed_text": "MYELODYSPLASTIC SYNDROME" } } ] }, { "_id": "135293379", "fda_orphan_drug": [ { "pubchem_sid": 135293379, "generic_name": "Antihemophilic factor (recombinant)", "trade_name": "ReFacto, Xyntha", "designated_date": "1996-02-08", "designation_status": "Designated/Approved", "marketing_approval_date": "2000-03-06", "sponsor": "Wyeth Pharmaceuticals, Inc.|P. O. Box 8299|Philadelphia|Pennsylvania|19101|United States", "orphan_designation": { "original_text": "For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).", "umls": [ "C0019069", "C2674164" ], "parsed_text": [ "Hemophilia A", "Hemorrhagic episodes" ] } }, { "pubchem_sid": 135293379, "generic_name": "Antihemophilic factor (recombinant)", "trade_name": "Kogenate", "designated_date": "1989-09-25", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment and prophylaxis of bleeding in patients with hemophilia A (not von Willebrand's disease)", "marketing_approval_date": "1993-02-25", "exclusivity_end_date": "2000-02-25", "sponsor": "Bayer Corporation|1884 Miles Avenue|Elkhart|Indiana|46515|United States", "orphan_designation": { "original_text": "Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A.", "umls": "C0019069", "parsed_text": "Hemophilia A" } } ] }, { "_id": "46506209", "fda_orphan_drug": [ { "pubchem_sid": 46506209, "generic_name": "Antihemophilic factor (recombinant)", "trade_name": "ReFacto, Xyntha", "designated_date": "1996-02-08", "designation_status": "Designated/Approved", "marketing_approval_date": "2000-03-06", "sponsor": "Wyeth Pharmaceuticals, Inc.|P. O. Box 8299|Philadelphia|Pennsylvania|19101|United States", "orphan_designation": { "original_text": "For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).", "umls": [ "C0019069", "C2674164" ], "parsed_text": [ "Hemophilia A", "Hemorrhagic episodes" ] } }, { "pubchem_sid": 46506209, "generic_name": "Antihemophilic factor (recombinant)", "trade_name": "Kogenate", "designated_date": "1989-09-25", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment and prophylaxis of bleeding in patients with hemophilia A (not von Willebrand's disease)", "marketing_approval_date": "1993-02-25", "exclusivity_end_date": "2000-02-25", "sponsor": "Bayer Corporation|1884 Miles Avenue|Elkhart|Indiana|46515|United States", "orphan_designation": { "original_text": "Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A.", "umls": "C0019069", "parsed_text": "Hemophilia A" } } ] }, { "_id": "347911209", "fda_orphan_drug": [ { "pubchem_sid": 347911209, "generic_name": "Antithrombin III (human)", "trade_name": "Thrombate III", "designated_date": "1984-11-26", "designation_status": "Designated/Approved", "marketing_approval_date": "1991-12-30", "exclusivity_end_date": "1998-12-30", "sponsor": "Bayer Corporation|Pharmaceutical Division, Biological Products|400 Morgan Lane|New Haven|Connecticut|6516|United States", "orphan_designation": { "original_text": "For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.", "umls": "C0333006", "parsed_text": "congenital deficiency" } }, { "pubchem_sid": 347911209, "generic_name": "Antithrombin III (human)", "trade_name": "ATnativ", "designated_date": "1985-02-08", "designation_status": "Designated/Approved", "marketing_approval_date": "1989-12-13", "exclusivity_end_date": "1996-12-13", "sponsor": "Pharmacia & Upjohn AB|Lindhagensgatan 133|Stockholm|Sweden", "orphan_designation": { "original_text": "For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.", "umls": [ "C0040038", "C2586031" ], "parsed_text": [ "Thromboembolism", "Hereditary antithrombin III deficiency" ] } }, { "pubchem_sid": 347911209, "generic_name": "Antithrombin III human", "designated_date": "1986-01-02", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "American National Red Cross|9312 Old Georgetown Road|Bethesda|Maryland|20814|United States", "orphan_designation": { "original_text": "Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.", "umls": [ "C0302148", "C3714660" ], "parsed_text": [ "Thrombosis", "Trauma" ] } } ] }, { "_id": "135346995", "fda_orphan_drug": [ { "pubchem_sid": 135346995, "generic_name": "Antithrombin III (human)", "trade_name": "Thrombate III", "designated_date": "1984-11-26", "designation_status": "Designated/Approved", "marketing_approval_date": "1991-12-30", "exclusivity_end_date": "1998-12-30", "sponsor": "Bayer Corporation|Pharmaceutical Division, Biological Products|400 Morgan Lane|New Haven|Connecticut|6516|United States", "orphan_designation": { "original_text": "For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.", "umls": "C0333006", "parsed_text": "congenital deficiency" } }, { "pubchem_sid": 135346995, "generic_name": "Antithrombin III (human)", "trade_name": "ATnativ", "designated_date": "1985-02-08", "designation_status": "Designated/Approved", "marketing_approval_date": "1989-12-13", "exclusivity_end_date": "1996-12-13", "sponsor": "Pharmacia & Upjohn AB|Lindhagensgatan 133|Stockholm|Sweden", "orphan_designation": { "original_text": "For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.", "umls": [ "C0040038", "C2586031" ], "parsed_text": [ "Thromboembolism", "Hereditary antithrombin III deficiency" ] } }, { "pubchem_sid": 135346995, "generic_name": "Antithrombin III human", "designated_date": "1986-01-02", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "American National Red Cross|9312 Old Georgetown Road|Bethesda|Maryland|20814|United States", "orphan_designation": { "original_text": "Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.", "umls": [ "C0302148", "C3714660" ], "parsed_text": [ "Thrombosis", "Trauma" ] } } ] }, { "_id": "160693080", "fda_orphan_drug": [ { "pubchem_sid": 160693080, "generic_name": "Antithrombin III human", "designated_date": "1986-01-02", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "American National Red Cross|9312 Old Georgetown Road|Bethesda|Maryland|20814|United States", "orphan_designation": { "original_text": "Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.", "umls": [ "C0302148", "C3714660" ], "parsed_text": [ "Thrombosis", "Trauma" ] } } ] }, { "_id": "404771575", "fda_orphan_drug": [ { "pubchem_sid": 404771575, "generic_name": 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"VectivBio AG|36 Aeschenvorstadt|Basel|Basel-Stadt|Switzerland", "orphan_designation": { "original_text": "Treatment of short bowel syndrome (SBS)", "umls": "C0036992", "parsed_text": "Short Bowel Syndrome" } } ] }, { "_id": "384061881", "fda_orphan_drug": [ { "pubchem_sid": 384061881, "generic_name": "apraglutide", "designated_date": "2018-12-20", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "VectivBio AG|36 Aeschenvorstadt|Basel|Basel-Stadt|Switzerland", "orphan_designation": { "original_text": "Treatment of short bowel syndrome (SBS)", "umls": "C0036992", "parsed_text": "Short Bowel Syndrome" } } ] }, { "_id": "384060674", "fda_orphan_drug": [ { "pubchem_sid": 384060674, "generic_name": "apraglutide", "designated_date": "2018-12-20", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "VectivBio AG|36 Aeschenvorstadt|Basel|Basel-Stadt|Switzerland", "orphan_designation": { "original_text": "Treatment of short bowel syndrome (SBS)", "umls": "C0036992", "parsed_text": "Short Bowel Syndrome" } } ] }, { "_id": "381126894", "fda_orphan_drug": [ { "pubchem_sid": 381126894, "generic_name": "apraglutide", "designated_date": "2018-12-20", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "VectivBio AG|36 Aeschenvorstadt|Basel|Basel-Stadt|Switzerland", "orphan_designation": { "original_text": "Treatment of short bowel syndrome (SBS)", "umls": "C0036992", "parsed_text": "Short Bowel Syndrome" } } ] }, { "_id": "160671599", "fda_orphan_drug": [ { "pubchem_sid": 160671599, "generic_name": "Arcitumomab", "designated_date": "1996-05-10", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Immunomedics, Inc.|300 American Road|Morris Plains|New Jersey|7950|United States", "orphan_designation": { "original_text": "Diagnosis 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"orphan_designation": { "original_text": "Treatment of MAGE-A3 positive non-small cell lung cancer", "umls": "C3539721", "parsed_text": "Non-Small Cell Lung Cancer" } }, { "pubchem_sid": 160693090, "generic_name": "astuprotimut-R", "designated_date": "2009-05-29", "designation_status": "Designated/Withdrawn", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "GlaxoSmithKline Biologicals, S.A.|Rue de l'Institut 89|B-1330 Rixensart|Belgium", "orphan_designation": { "original_text": "Treatment of MAGE-A3 positive stages IIb to IV malignant melanoma", "umls": "C0025202", "parsed_text": "Malignant Melanoma" } } ] }, { "_id": "135342748", "fda_orphan_drug": [ { "pubchem_sid": 135342748, "generic_name": "astuprotimut-R", "designated_date": "2009-05-29", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "GlaxoSmithKline Biologicals, S.A.|Rue de I'Institut 89|B-1330 Rixensart|Belgium", "orphan_designation": { 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Inc.|2400 Broadway|Santa Monica|California|90404|United States", "orphan_designation": { "original_text": "Treatment of follicular lymphoma.", "umls": "C0024301", "parsed_text": "follicular lymphoma" } }, { "pubchem_sid": 374364294, "generic_name": "axicabtagene ciloleucel", "designated_date": "2020-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Kite Pharma, Inc.|2400 Broadway|Santa Monica|California|90404|United States", "orphan_designation": { "original_text": "Treatment of extranodal marginal zone lymphoma", "umls": "C1367654", "parsed_text": "Marginal zone lymphoma" } } ] }, { "_id": "347911476", "fda_orphan_drug": [ { "pubchem_sid": 347911476, "generic_name": "axicabtagene ciloleucel", "trade_name": "Yescarta", "designated_date": "2016-04-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or 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"designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "OncoVac Corporation|P. O. Box 970|Pacific Palisades|California|90272|United States", "orphan_designation": { "original_text": "Treatment of stage IIb through IV metastatic melanoma", "umls": "C0278883", "parsed_text": "Metastatic melanoma" } } ] }, { "_id": "441073676", "fda_orphan_drug": [ { "pubchem_sid": 441073676, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "440701517", "fda_orphan_drug": [ { "pubchem_sid": 440701517, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "440064057", "fda_orphan_drug": [ { "pubchem_sid": 440064057, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "439508002", "fda_orphan_drug": [ { "pubchem_sid": 439508002, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "438644584", "fda_orphan_drug": [ { "pubchem_sid": 438644584, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "438536569", "fda_orphan_drug": [ { "pubchem_sid": 438536569, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "405235684", "fda_orphan_drug": [ { "pubchem_sid": 405235684, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "404614577", "fda_orphan_drug": [ { "pubchem_sid": 404614577, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "387113800", "fda_orphan_drug": [ { "pubchem_sid": 387113800, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "385840929", "fda_orphan_drug": [ { "pubchem_sid": 385840929, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "385834696", "fda_orphan_drug": [ { "pubchem_sid": 385834696, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "384385661", "fda_orphan_drug": [ { "pubchem_sid": 384385661, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "383548014", "fda_orphan_drug": [ { "pubchem_sid": 383548014, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "381395584", "fda_orphan_drug": [ { "pubchem_sid": 381395584, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "377311345", "fda_orphan_drug": [ { "pubchem_sid": 377311345, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "376051446", "fda_orphan_drug": [ { "pubchem_sid": 376051446, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "348746094", "fda_orphan_drug": [ { "pubchem_sid": 348746094, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "348397129", "fda_orphan_drug": [ { "pubchem_sid": 348397129, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "347913992", "fda_orphan_drug": [ { "pubchem_sid": 347913992, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "347636808", "fda_orphan_drug": [ { "pubchem_sid": 347636808, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "342544612", "fda_orphan_drug": [ { "pubchem_sid": 342544612, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "340507965", "fda_orphan_drug": [ { "pubchem_sid": 340507965, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "318153988", "fda_orphan_drug": [ { "pubchem_sid": 318153988, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "313075802", "fda_orphan_drug": [ { "pubchem_sid": 313075802, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "176331282", "fda_orphan_drug": [ { "pubchem_sid": 176331282, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "162224794", "fda_orphan_drug": [ { "pubchem_sid": 162224794, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "50071585", "fda_orphan_drug": [ { "pubchem_sid": 50071585, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "50071584", "fda_orphan_drug": [ { "pubchem_sid": 50071584, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "50071583", "fda_orphan_drug": [ { "pubchem_sid": 50071583, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "49873563", "fda_orphan_drug": [ { "pubchem_sid": 49873563, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "605350", "fda_orphan_drug": [ { "pubchem_sid": 605350, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "4814", "fda_orphan_drug": [ { "pubchem_sid": 4814, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "387079919", "fda_orphan_drug": [ { "pubchem_sid": 387079919, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "377014793", "fda_orphan_drug": [ { "pubchem_sid": 377014793, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "404425800", "fda_orphan_drug": [ { "pubchem_sid": 404425800, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "387079921", "fda_orphan_drug": [ { "pubchem_sid": 387079921, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "387079920", "fda_orphan_drug": [ { "pubchem_sid": 387079920, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "316962251", "fda_orphan_drug": [ { "pubchem_sid": 316962251, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "315444088", "fda_orphan_drug": [ { "pubchem_sid": 315444088, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "252402155", "fda_orphan_drug": [ { "pubchem_sid": 252402155, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "144206731", "fda_orphan_drug": [ { "pubchem_sid": 144206731, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "144204057", "fda_orphan_drug": [ { "pubchem_sid": 144204057, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "144074916", "fda_orphan_drug": [ { "pubchem_sid": 144074916, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "126676473", "fda_orphan_drug": [ { "pubchem_sid": 126676473, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "546764", "fda_orphan_drug": [ { "pubchem_sid": 546764, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "440790689", "fda_orphan_drug": [ { "pubchem_sid": 440790689, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "438474345", "fda_orphan_drug": [ { "pubchem_sid": 438474345, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "406582657", "fda_orphan_drug": [ { "pubchem_sid": 406582657, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "374155019", "fda_orphan_drug": [ { "pubchem_sid": 374155019, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "346444061", "fda_orphan_drug": [ { "pubchem_sid": 346444061, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "335958847", "fda_orphan_drug": [ { "pubchem_sid": 335958847, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "318238404", "fda_orphan_drug": [ { "pubchem_sid": 318238404, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "316898684", "fda_orphan_drug": [ { "pubchem_sid": 316898684, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "254759847", "fda_orphan_drug": [ { "pubchem_sid": 254759847, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "204380020", "fda_orphan_drug": [ { "pubchem_sid": 204380020, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "196105735", "fda_orphan_drug": [ { "pubchem_sid": 196105735, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "163814587", "fda_orphan_drug": [ { "pubchem_sid": 163814587, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "126655275", "fda_orphan_drug": [ { "pubchem_sid": 126655275, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "126629464", "fda_orphan_drug": [ { "pubchem_sid": 126629464, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "440681435", "fda_orphan_drug": [ { "pubchem_sid": 440681435, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "387166216", "fda_orphan_drug": [ { "pubchem_sid": 387166216, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "376227004", "fda_orphan_drug": [ { "pubchem_sid": 376227004, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "341139910", "fda_orphan_drug": [ { "pubchem_sid": 341139910, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "268734448", "fda_orphan_drug": [ { "pubchem_sid": 268734448, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "162228041", "fda_orphan_drug": [ { "pubchem_sid": 162228041, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "124766072", "fda_orphan_drug": [ { "pubchem_sid": 124766072, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "103914703", "fda_orphan_drug": [ { "pubchem_sid": 103914703, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "52518470", "fda_orphan_drug": [ { "pubchem_sid": 52518470, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "8149211", "fda_orphan_drug": [ { "pubchem_sid": 8149211, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "434131544", "fda_orphan_drug": [ { "pubchem_sid": 434131544, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "373567635", "fda_orphan_drug": [ { "pubchem_sid": 373567635, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "310267241", "fda_orphan_drug": [ { "pubchem_sid": 310267241, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "162180419", "fda_orphan_drug": [ { "pubchem_sid": 162180419, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "52518469", "fda_orphan_drug": [ { "pubchem_sid": 52518469, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "7978755", "fda_orphan_drug": [ { "pubchem_sid": 7978755, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "438451119", "fda_orphan_drug": [ { "pubchem_sid": 438451119, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "434142455", "fda_orphan_drug": [ { "pubchem_sid": 434142455, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "433925319", "fda_orphan_drug": [ { "pubchem_sid": 433925319, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "350086297", "fda_orphan_drug": [ { "pubchem_sid": 350086297, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "349989661", "fda_orphan_drug": [ { "pubchem_sid": 349989661, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "348283279", "fda_orphan_drug": [ { "pubchem_sid": 348283279, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "347673985", "fda_orphan_drug": [ { "pubchem_sid": 347673985, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "312693845", "fda_orphan_drug": [ { "pubchem_sid": 312693845, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "312228282", "fda_orphan_drug": [ { "pubchem_sid": 312228282, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "224054832", "fda_orphan_drug": [ { "pubchem_sid": 224054832, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "134981168", "fda_orphan_drug": [ { "pubchem_sid": 134981168, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "103770541", "fda_orphan_drug": [ { "pubchem_sid": 103770541, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "99381480", "fda_orphan_drug": [ { "pubchem_sid": 99381480, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "46504727", "fda_orphan_drug": [ { "pubchem_sid": 46504727, "generic_name": "Bacitracin", "designated_date": "1984-03-13", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "A. L. Laboratories, Inc.|One Executive Drive|P.O. Box 1399|Fort Lee|New Jersey|7024|United States", "orphan_designation": { "original_text": "Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.", "umls": "C0014358", "parsed_text": "Pseudomembranous enterocolitis" } } ] }, { "_id": "440790690", "fda_orphan_drug": [ { "pubchem_sid": 440790690, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "178103461", "fda_orphan_drug": [ { "pubchem_sid": 178103461, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "135321271", "fda_orphan_drug": [ { "pubchem_sid": 135321271, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "103771251", "fda_orphan_drug": [ { "pubchem_sid": 103771251, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "50067184", "fda_orphan_drug": [ { "pubchem_sid": 50067184, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "46505169", "fda_orphan_drug": [ { "pubchem_sid": 46505169, "generic_name": "Basiliximab", "trade_name": "Simulect", "designated_date": "1997-12-12", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.", "marketing_approval_date": "1998-05-12", "exclusivity_end_date": "2005-05-12", "sponsor": "Novartis Pharmaceuticals Corporation|59 Route 10|East Hanover|New Jersey|7936|United States", "orphan_designation": { "original_text": "Prophylaxis of solid organ rejection.", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "434122177", "fda_orphan_drug": [ { "pubchem_sid": 434122177, "generic_name": "belantamab mafodotin-blmf", "trade_name": "BLENREP", "designated_date": "2017-06-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "marketing_approval_date": "2020-08-05", "exclusivity_end_date": "2027-08-05", "exclusivity_protected_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "sponsor": "GlaxoSmithKline Intellectual Property Development Ltd.|980 GREAT WEST ROAD|BRENTFORD|MIDDLESEX|TW89GS|United Kingdom", "orphan_designation": { "original_text": "Treatment of multiple myeloma", "umls": "C0026764", "parsed_text": "Multiple Myeloma" } } ] }, { "_id": "405226462", "fda_orphan_drug": [ { "pubchem_sid": 405226462, "generic_name": "belantamab mafodotin-blmf", "trade_name": "BLENREP", "designated_date": "2017-06-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "marketing_approval_date": "2020-08-05", "exclusivity_end_date": "2027-08-05", "exclusivity_protected_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "sponsor": "GlaxoSmithKline Intellectual Property Development Ltd.|980 GREAT WEST ROAD|BRENTFORD|MIDDLESEX|TW89GS|United Kingdom", "orphan_designation": { "original_text": "Treatment of multiple myeloma", "umls": "C0026764", "parsed_text": "Multiple Myeloma" } } ] }, { "_id": "404719842", "fda_orphan_drug": [ { "pubchem_sid": 404719842, "generic_name": "belantamab mafodotin-blmf", "trade_name": "BLENREP", "designated_date": "2017-06-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "marketing_approval_date": "2020-08-05", "exclusivity_end_date": "2027-08-05", "exclusivity_protected_indication": "for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent", "sponsor": "GlaxoSmithKline Intellectual Property Development Ltd.|980 GREAT WEST ROAD|BRENTFORD|MIDDLESEX|TW89GS|United Kingdom", "orphan_designation": { "original_text": "Treatment of multiple myeloma", "umls": "C0026764", "parsed_text": "Multiple Myeloma" } } ] }, { "_id": "347910359", "fda_orphan_drug": [ { "pubchem_sid": 347910359, "generic_name": "belatacept", "trade_name": "Nulojix", "designated_date": "2008-02-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of organ rejection in adult patients receiving kidney transplants", "marketing_approval_date": "2011-06-15", "exclusivity_end_date": "2018-06-15", "sponsor": "Bristol-Myers Squibb Company|P. O. Box 4000|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prophylaxis of organ rejection in renal allograft recipients", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "178103474", "fda_orphan_drug": [ { "pubchem_sid": 178103474, "generic_name": "belatacept", "trade_name": "Nulojix", "designated_date": "2008-02-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of organ rejection in adult patients receiving kidney transplants", "marketing_approval_date": "2011-06-15", "exclusivity_end_date": "2018-06-15", "sponsor": "Bristol-Myers Squibb Company|P. O. Box 4000|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prophylaxis of organ rejection in renal allograft recipients", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "135283321", "fda_orphan_drug": [ { "pubchem_sid": 135283321, "generic_name": "belatacept", "trade_name": "Nulojix", "designated_date": "2008-02-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of organ rejection in adult patients receiving kidney transplants", "marketing_approval_date": "2011-06-15", "exclusivity_end_date": "2018-06-15", "sponsor": "Bristol-Myers Squibb Company|P. O. Box 4000|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prophylaxis of organ rejection in renal allograft recipients", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "131287524", "fda_orphan_drug": [ { "pubchem_sid": 131287524, "generic_name": "belatacept", "trade_name": "Nulojix", "designated_date": "2008-02-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prophylaxis of organ rejection in adult patients receiving kidney transplants", "marketing_approval_date": "2011-06-15", "exclusivity_end_date": "2018-06-15", "sponsor": "Bristol-Myers Squibb Company|P. O. Box 4000|Princeton|New Jersey|8543|United States", "orphan_designation": { "original_text": "Prophylaxis of organ rejection in renal allograft recipients", "umls": "C0815080", "parsed_text": "organ rejection" } } ] }, { "_id": "404859106", "fda_orphan_drug": [ { "pubchem_sid": 404859106, "generic_name": "bempegaldesleukin", "designated_date": "2020-04-17", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Nektar Therapeutics|455 Mission Bay Blvd, South|San Francisco|California|94158|United States", "orphan_designation": { "original_text": "Treatment of Stage IIb to Stage IV melanoma", "umls": "C0025202", "parsed_text": "melanoma" } } ] }, { "_id": "404772580", "fda_orphan_drug": [ { "pubchem_sid": 404772580, "generic_name": "bempegaldesleukin", "designated_date": "2020-04-17", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Nektar Therapeutics|455 Mission Bay Blvd, South|San Francisco|California|94158|United States", "orphan_designation": { "original_text": "Treatment of Stage IIb to Stage IV melanoma", "umls": "C0025202", "parsed_text": "melanoma" } } ] }, { "_id": "404720042", "fda_orphan_drug": [ { "pubchem_sid": 404720042, "generic_name": "bempegaldesleukin", "designated_date": "2020-04-17", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Nektar Therapeutics|455 Mission Bay Blvd, South|San Francisco|California|94158|United States", "orphan_designation": { "original_text": "Treatment of Stage IIb to Stage IV melanoma", "umls": "C0025202", "parsed_text": "melanoma" } } ] }, { "_id": "381128181", "fda_orphan_drug": [ { "pubchem_sid": 381128181, "generic_name": "bempegaldesleukin", "designated_date": "2020-04-17", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Nektar Therapeutics|455 Mission Bay Blvd, South|San Francisco|California|94158|United States", "orphan_designation": { "original_text": "Treatment of Stage IIb to Stage IV melanoma", "umls": "C0025202", "parsed_text": "melanoma" } } ] }, { "_id": "402356184", "fda_orphan_drug": [ { "pubchem_sid": 402356184, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 402356184, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 402356184, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "402355846", "fda_orphan_drug": [ { "pubchem_sid": 402355846, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 402355846, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 402355846, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "347911271", "fda_orphan_drug": [ { "pubchem_sid": 347911271, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 347911271, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 347911271, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "223366009", "fda_orphan_drug": [ { "pubchem_sid": 223366009, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 223366009, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 223366009, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "160704150", "fda_orphan_drug": [ { "pubchem_sid": 160704150, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 160704150, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 160704150, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "135339902", "fda_orphan_drug": [ { "pubchem_sid": 135339902, "generic_name": "benralizumab", "designated_date": "2019-08-26", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|1800 Concord Pike|P.O. Box 8355|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic esophagitis", "umls": "C0341106", "parsed_text": "Eosinophilic esophagitis" } }, { "pubchem_sid": 135339902, "generic_name": "benralizumab", "designated_date": "2018-11-21", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of eosinophilic granulomatosis with polyangiitis", "umls": "C0008728", "parsed_text": "Eosinophilic granulomatosis with polyangiitis" } }, { "pubchem_sid": 135339902, "generic_name": "benralizumab", "designated_date": "2019-02-01", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "AstraZeneca Pharmaceuticals LP|P. O. Box 8355|1800 Concord Pike|Wilmington|Delaware|19803|United States", "orphan_designation": { "original_text": "Treatment of hypereosinophilic syndrome", "umls": "C1540912", "parsed_text": "Hypereosinophilic syndrome" } } ] }, { "_id": "347910369", "fda_orphan_drug": [ { "pubchem_sid": 347910369, "generic_name": "Beractant", "designated_date": "1993-12-20", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ross Laboratories|625 Cleveland Avenue|Columbus|Ohio|43215|United States", "orphan_designation": { "original_text": "Treatment of full-term newborn infants with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis.", "umls": [ "C0025048", "C0031190", "C0032285", "C0243026", "C1145670" ], "parsed_text": [ "Meconium Aspiration Syndrome", "Persistent pulmonary hypertension of the newborn", "Pneumonia", "Sepsis", "Respiratory Failure" ] } }, { "pubchem_sid": 347910369, "generic_name": "Beractant", "trade_name": "Survanta intratracheal suspension", "designated_date": "1986-02-05", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of (\"rescue\") of premature infants with RDS confirmed by x-ray and requiring mechanical ventilation", "marketing_approval_date": "1991-07-01", "exclusivity_end_date": "1998-07-01", "sponsor": "Ross Laboratories|625 Cleveland Avenue|Columbus|Ohio|43215|United States", "orphan_designation": { "original_text": "Treatment of neonatal respiratory distress syndrome", "umls": "C0035220", "parsed_text": "Neonatal Respiratory Distress Syndrome" } }, { "pubchem_sid": 347910369, "generic_name": "Beractant", "trade_name": "Survanta intratracheal suspension", "designated_date": "1986-02-05", "designation_status": "Designated/Approved", "approved_labeled_indication": "Prevention of RDS (hyaline membrane disease) in premature infants less than 1250 grams birthweight or with 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Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 440790701, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 440790701, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 440790701, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 440790701, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 440790701, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 440790701, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "404720407", "fda_orphan_drug": [ { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 404720407, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 404720407, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "135351517", "fda_orphan_drug": [ { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 135351517, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 135351517, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "81065599", "fda_orphan_drug": [ { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 81065599, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 81065599, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "49895113", "fda_orphan_drug": [ { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 49895113, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 49895113, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "46505347", "fda_orphan_drug": [ { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 46505347, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 46505347, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "10147", "fda_orphan_drug": [ { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "designated_date": "1991-12-05", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharmaceuticals, Inc.|106 Allen Road|3rd Floor|Basking Ridge|New Jersey|7920|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-30", "exclusivity_end_date": "1996-12-30", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "trade_name": "Dysport", "designated_date": "1999-10-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of lower limb spasticity in pediatric patients 2 years of age and older", "marketing_approval_date": "2016-07-29", "exclusivity_end_date": "2023-07-29", "exclusivity_protected_indication": "Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older", "sponsor": "Ipsen Biopharmaceuticals, Inc.|650 East Kendall Street|Cambridge|Massachusetts|2142|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Contractures" ] } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "designated_date": "1989-03-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Porton International, Inc.|1155 15th Street, N.W., #315|Washington|District of Columbia|20005|United States", "orphan_designation": { "original_text": "Treatment of essential blepharospasm.", "umls": "C2930898", "parsed_text": "Essential blepharospasm" } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1986-08-20", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.", "marketing_approval_date": "2000-12-21", "exclusivity_end_date": "2007-12-21", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of cervical dystonia.", "umls": "C0152116", "parsed_text": "Cervical Dystonia" } }, { "pubchem_sid": 10147, "generic_name": "botulinum toxin type A", "trade_name": "Botox", "designated_date": "1991-12-06", "designation_status": "Designated/Approved", "approved_labeled_indication": "BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.", "marketing_approval_date": "2019-06-20", "exclusivity_end_date": "2026-06-20", "exclusivity_protected_indication": "For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age", "sponsor": "Allergan, Inc.|2525 Dupont Drive|T1-2A|Irvine|California|92623|United States", "orphan_designation": { "original_text": "Treatment of dynamic muscle contracture in pediatric cerebral palsy patients", "umls": [ "C0007789", "C0009917" ], "parsed_text": [ "Cerebral Palsy", "Muscle contracture" ] } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "designated_date": "1998-08-12", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Biopharm Limited|1 Bath Road|Maidenhead|Berkshire, SL6 4UH|United Kingdom", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } }, { "pubchem_sid": 10147, "generic_name": "Botulinum toxin type A", "trade_name": "Botox", "designated_date": "1984-03-22", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)", "marketing_approval_date": "1989-12-29", "exclusivity_end_date": "1996-12-29", "sponsor": "Allergan, Inc.|2525 Dupont Drive|P.O. Box 19534|Irvine|California|92713|United States", "orphan_designation": { "original_text": "Treatment of strabismus and blepharospasms", "umls": [ "C0005747", "C0038379" ], "parsed_text": [ "Blepharospasms", "Strabismus" ] } } ] }, { "_id": "312525292", "fda_orphan_drug": [ { "pubchem_sid": 312525292, "generic_name": "Botulinum toxin type F", "designated_date": "1991-10-24", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Ipsen Limited|27 Maple Street|Milford|Massachusetts|1757|United States", "orphan_designation": { "original_text": "Treatment of spasmodic torticollis (cervical dystonia).", "umls": "C0152116", "parsed_text": "Spasmodic torticollis" } } ] }, { "_id": "404720159", "fda_orphan_drug": [ { "pubchem_sid": 404720159, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "381123584", "fda_orphan_drug": [ { "pubchem_sid": 381123584, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "347910092", "fda_orphan_drug": [ { "pubchem_sid": 347910092, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "178101597", "fda_orphan_drug": [ { "pubchem_sid": 178101597, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "160745599", "fda_orphan_drug": [ { "pubchem_sid": 160745599, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": 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"designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "56311848", "fda_orphan_drug": [ { "pubchem_sid": 56311848, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "7978945", "fda_orphan_drug": [ { "pubchem_sid": 7978945, "generic_name": "Ciliary neurotrophic factor", "designated_date": "1992-01-30", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Regeneron Pharmaceuticals Inc|777 Old Saw Mill River Road|Tarrytown|New York|10591|United States", "orphan_designation": { "original_text": "Treatment of amyotrophic lateral sclerosis.", "umls": "C0002736", "parsed_text": "Amyotrophic Lateral Sclerosis" } } ] }, { "_id": "404772201", "fda_orphan_drug": [ { "pubchem_sid": 404772201, "generic_name": "mecasermin rinfabate", "trade_name": "Iplex", "designated_date": "2002-05-17", "designation_status": "Designated/Approved", "approved_labeled_indication": "Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone", "marketing_approval_date": "2005-12-12", "exclusivity_end_date": "2012-12-12", "sponsor": "Insmed, Inc.|10 Finderne Ave|Building 10|Bridgewater|New Jersey|8807|United States", "orphan_designation": { "original_text": "Treatment of growth hormone insensitivity syndrome (GHIS)", "umls": "C4318479", "parsed_text": "Growth Hormone Insensitivity Syndrome" } }, { "pubchem_sid": 404772201, "generic_name": "mecasermin rinfabate", "designated_date": "2012-09-20", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Premacure AB, a member of Shire Group of Companies|Dag Hammarskjolds vag 10B|Uppsala Science Park|Uppsala|Sweden", "orphan_designation": { "original_text": "Prevention of retinopathy of prematurity in premature infants born at risk for the disease", "umls": "C0035344", "parsed_text": "Retinopathy of Prematurity" } }, { "pubchem_sid": 404772201, "generic_name": "rhIGF-I/rhIGFBP-3", "designated_date": "2003-12-09", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "Insmed, Inc.|10 Finderne Ave|Building 10|Bridgewater|New Jersey|8807|United States", "orphan_designation": { "original_text": "Treatment of extreme insulin resistance syndromes (type A, Rabson-Mendenhall syndrome, Leprechaunism, Type B syndrome)", "umls": [ "C0265344", "C0271695", "C4313258" ], "parsed_text": [ "Leprechaunism", "Rabson-Mendenhall Syndrome", "Extreme insulin resistance" ] } }, { "pubchem_sid": 404772201, "generic_name": "mecasermin rinfabate", "designated_date": "2012-07-23", "designation_status": "Designated", "approval_status": "Not FDA Approved for Orphan Indication", "sponsor": "PCUT BioPartners, Inc.|2196 Glenkirk Drive|San Jose|California|95124|United States", "orphan_designation": { "original_text": "Treatment of amyotropic lateral sclerosis", "umls": "C0154682", "parsed_text": "Lateral Sclerosis" } } ] }, { "_id": "135325697", "fda_orphan_drug": [ { "pubchem_sid": 135325697, "generic_name": "mecasermin rinfabate", "trade_name": "Iplex", "designated_date": "2002-05-17", 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