Court Supports Catalyst’s Appeal for Market Exclusivity for Firdapse

Court Supports Catalyst’s Appeal for Market Exclusivity for Firdapse

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Court Supports Catalyst’s Appeal for Market Exclusivity for Firdapse

A federal appeals court has ruled that the U.S. Food and Drug Administration (FDA) should not have approved Ruzurgi (amifampridine) for the treatment of children with Lambert-Eaton myasthenic syndrome (LEMS). The decision by the U.S. 11th Circuit Court of Appeals is a win for Catalyst Pharmaceuticals, which sued the FDA and several other parties over Ruzurgi’s approval in 2019, stating it violated the company’s right to orphan drug exclusivity for Firdapse — a therapy chemically similar…

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