Firdapse FDA Approval History
Last updated by Judith Stewart, BPharm on June 25, 2024.
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 5 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
Date | Article |
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May 30, 2024 | Approval Catalyst Pharmaceuticals Receives U.S. FDA Approval for Increased Maximum Daily Dose for Firdapse |
Sep 29, 2022 | Approval Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for Firdapse Expanding Patient Population to Include Pediatric Patients |
Nov 28, 2018 | Approval FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome |
May 29, 2018 | Catalyst Pharmaceuticals Announces FDA Acceptance of NDA and Priority Review Status for Firdapse (amifampridine phosphate) for Lambert-Eaton Myasthenic Syndrome |
Mar 29, 2018 | Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome |
Feb 12, 2018 | Catalyst Pharmaceuticals Announces Plans to Resubmit New Drug Application for Firdapse |
Dec 8, 2016 | Catalyst Pharmaceuticals Provides Update on its Clinical Trial for Patients with Congenital Myasthenic Syndromes |
Apr 26, 2016 | Catalyst Pharmaceuticals Provides Regulatory Update on Firdapse |
Feb 17, 2016 | Catalyst Pharmaceuticals Receives Refusal to File Letter From the FDA on Its NDA for Firdapse |
Dec 17, 2015 | Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes |
Further information
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