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Treats Lambert-Eaton myasthenic syndrome (LEMS). Sold as Firdapse. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Amifampridine Phosphate (sold as Firdapse), first approved Nov 28, 2018, with 2 new uses approved and 0 published complete response letters.
First approved: Nov 28, 2018
Applications: 2
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $218M
Orphan exclusivity until: Sep 29, 2029
First approved in the EU: Dec 23, 2009
First approved in Japan: Sep 24, 2024
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 70 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Firdapse, new ingredientA drug with a new active ingredient indicated for the improvement of muscle weakness in patients with Lambert-Eaton myasthenic syndrome. · DyDo Pharma, Inc. · Sep 24, 2024
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Lupin