Catalyst Will Seek FDA Approval of Firdapse for Children

Catalyst Will Seek FDA Approval of Firdapse for Children

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Catalyst Will Seek FDA Approval of Firdapse for Children

Catalyst Pharmaceuticals plans to file an application with the U.S. Food and Drug Administration (FDA) requesting that the use of Firdapse (amifampridine), an approved oral therapy for adults with Lambert-Eaton myasthenic syndrome (LEMS), be expanded to children. The announcement came after the company received a favorable decision from a federal appeals court in its appeal to reverse the FDA’s approval of Ruzurgi (amifampridine) — a therapy similar to Firdapse and approved for children, ages 6–16, with LEMS.…

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