FDA accepts Catalyst's sNDA to increase FIRDAPSE max dose to 100 mg; PDUFA June 4, 2024

CATALYST PHARMACEUTICALS, INC.

FDA accepted supplemental NDA to increase FIRDAPSE maximum daily dose from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome.
Prescription Drug User Fee Act action date set for June 4, 2024.
FIRDAPSE is currently approved for adults and children ages 6-17 with LEMS.
Chairman and CEO Patrick J. McEnany highlighted the milestone for addressing patient needs.

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