Treats Lambert-Eaton myasthenic syndrome (LEMS). NDA 208078, held by Catalyst Pharms. Amifampridine Phosphate.
As of Nov 13, 2026, NDA 208078 (Firdapse), held by Catalyst Pharms, was first approved by FDA on Nov 28, 2018, with 5 approved supplements and 0 published complete response letters.
FIRDAPSE is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.
| May 30, 2024 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 28, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FirdapseEQ 10MG BASE · tablet;oral | Amifampridine Phosphate | RxReference drug |
| Jul 17, 2025 | Supplement 15Manufacturing · Standard review | Approved | |
| May 30, 2024 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| May 15, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Sep 29, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Mar 1, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Nov 28, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
