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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: amifampridine
Trade Name: Firdapse
Date Designated: 11/12/2009
Orphan Designation: Treatment of Lambert-Eaton Myasthenic Syndrome
Orphan Designation Status: Designated/Approved
Catalyst Pharmaceuticals, Inc.
355 Alhambra Circle
Suite 1250
Coral Gables, Florida 33134
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: amifampridine
Trade Name: Firdapse
Marketing Approval Date: 11/28/2018
Approved Labeled Indication: Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults
Exclusivity End Date: 11/28/2025 
Exclusivity Protected Indication* :  Treatment of Lambert-Eaton myasthenic syndrome (LEMS)
2 Generic Name: amifampridine
Trade Name: Firdapse
Marketing Approval Date: 09/29/2022
Approved Labeled Indication: Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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