Posted by Michael Wonder on 30 May 2018
Catalyst Pharmaceuticals announces FDA acceptance of NDA and priority review status for Firdapse (amifampridine phosphate) for Lambert-Eaton myasthenic syndrome
29 May 2018 - Catalyst Pharmaceuticals announced today that its new drug application for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome has been accepted for a priority review by the U.S. FDA.
The FDA has set a Prescription Drug User Fee Act action date of 28 November 2018. The submission is supported by positive results from two Phase 3 studies.
