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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 phosphate
Trade Name:  FIRDAPSE
Date Designated:  11/12/2009
Orphan Designation:  Treatment of Lambert-Eaton Myasthenic Syndrome
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/28/2018 
Approved Labeled Indication:  FIRDAPSE® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Exclusivity End Date:    11/28/2025 
Exclusivity Protected Indication* :  FIRDAPSE® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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