Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse

Catalyst Pharmaceuticals (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Firdapse® (amifampridine) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).

As quoted in the press release:

“We are pleased to reach this regulatory milestone and believe that our NDA submission contains all of the necessary information to satisfy the FDA requirements,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals, Inc. “This important milestone is the culmination of a strong collaboration and commitment among the patients, physicians and Catalyst employees who have worked diligently to advance Firdapse and to further expand access to an FDA-approved product to all LEMS patients. We look forward to continuing to work with the FDA during the review process and to a potential future launch of Firdapse, if it is approved.”

Click here to read the full press release.