Catalyst Pharmaceuticals, Inc. announced that the District Court which heard Catalyst's Lawsuit against the FDA has entered summary judgment in favor of Catalyst. The District Court's order implements the prior decision of the U.S. Court of Appeals for the 11th Circuit, which ruled that the United States Food and Drug Administration's ("FDA") approval of Ruzurgi® (Jacobus Pharmaceutical Company, Inc.'s amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg under the Orphan Drug Act. As a result of the District Court's order, the FDA marketing approval previously granted for Ruzurgi® is no longer valid.
Patrick J. McEnany, Catalyst's Chairman and CEO stated, "The entire Catalyst patient assistance team has been preparing for this likely outcome since the decision of the U.S. Circuit Court of Appeals for the 11th Circuit was reported. We have added additional care coordinators to our Catalyst Pathways® team, and our entire patient-focused team is ready to assist LEMS patients that are currently being treated with Ruzurgi® to provide a smooth, uninterrupted transition to FIRDAPSE."
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