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Firdapse Approval Status

  • FDA approved: No
  • Brand name: Firdapse
  • Generic name: amifampridine phosphate
  • Company: Catalyst Pharmaceuticals, Inc.
  • Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)

Firdapse (amifampridine phosphate) is a neuronal potassium channel blocker in development for the treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Development Status and FDA Approval Process for Firdapse

DateArticle
Apr 26, 2016Catalyst Pharmaceuticals Provides Regulatory Update on Firdapse
Feb 17, 2016Catalyst Pharmaceuticals Receives Refusal to File Letter From the FDA on Its NDA for Firdapse
Dec 17, 2015Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes

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