FDA Approves Catalyst Pharmaceuticals’ Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome

On Nov. 28, the U.S. Food and Drug Administration (FDA) announced the approval of Firdapse (amifampridine phosphate) for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS). Firdapse, developed by Catalyst Pharmaceuticals, is an oral potassium channel inhibitor designed to prolong signals released from nerves and allow greater stimulation of muscles. This is the eighth . . .

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Catalyst Pharmaceuticals Submits New Drug Application to FDA for Firdapse to Treat LEMS

Catalyst Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug amifampridine phosphate (brand name Firdapse) for the treatment of people with Lambert-Eaton myasthenic syndrome (LEMS). The FDA has 60 days to determine whether the NDA is complete and acceptable for filing. If the FDA . . .

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