US Court Won’t Rehear Its Ruling Overturning Ruzurgi’s FDA Approval

US Court Won’t Rehear Its Ruling Overturning Ruzurgi’s FDA Approval

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US Court Won’t Rehear Its Ruling Overturning Ruzurgi’s FDA Approval

A federal appeals court has denied Jacobus Pharmaceutical’s petition to rehear its prior ruling overturning the U.S. approval of the company’s Ruzurgi to treat children with Lambert-Eaton myasthenic syndrome (LEMS). The decision is a victory for Catalyst Pharmaceuticals, which sued the U.S. Food and Drug Administration over Ruzurgi’s approval in 2019. The issue at hand is that the active agent in Ruzurgi, called amifampridine, is also the active ingredient in Catalyst’s Firdapse, which was granted the…

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