Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE® Expanding Patient Population to Include Pediatric Patients
CORAL GABLES, Fla., Sept. 29, 2022 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental New Drug Application (“sNDA”) to expand the indicated age range for FIRDAPSE® (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). FIRDAPSE is currently approved in the U.S. and Canada for the treatment of LEMS in adult patients.
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