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  • Regulatory NewsRegulatory News

    Catalyst Sues FDA Over Approval of Rival Drug

    Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Ruzurgi, which was approved by FDA in May for children with LEMS, will likely compete off-label with Catalyst’s Firdapse (amifampridine), which first won approval in November 2018 but has a list price about twice as...