Catalyst Pharmaceuticals files federal lawsuit against FDA in relation to approval of Ruzurgi

Catalyst Pharmaceuticals, Inc. announced it has filed a suit against the FDA and several related parties challenging the recent approval of a new drug application and related drug labeling for Jacobus Pharmaceutical Company’s drug Ruzurgi for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in pediatric patients. The complaint was filed in the United States District Court for the Southern District of Florida. The complaint alleges that the defendants’ approval of Ruzurgi violated multiple provisions of FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA); violated Catalyst’s statutory rights to Orphan Drug Exclusivity and to New Chemical Entity Exclusivity under the FDCA; and was in multiple other respects arbitrary, capricious, and contrary to law, in violation of the Administrative Procedure Act. Among other remedies, the suit seeks an order vacating the FDA's approval of Ruzurgi.

Catalyst's new drug application for Firdapse (amifampridine) 10 mg tablets for the treatment of adults with LEMS was recently approved by the FDA, and Firdapse is now commercially available in the United States. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA.