Firdapse FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 12, 2022.
FDA Approved: Yes (First approved November 28, 2018)
Brand name: Firdapse
Generic name: amifampridine phosphate
Dosage form: Tablets
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome
Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults and pediatric patients six years of age and older.
- LEMS is a rare autoimmune disease that affects approximately 1 in 100,000 people in the United States. The most common symptoms are proximal muscle weakness and fatigue, which can be life threatening when the weakness involves respiratory muscles.
- Firdapse is taken orally in divided doses (3 to 4 times daily).
- The most common (> 10%) adverse reactions are paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms.
Development timeline for Firdapse
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
