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# Catalyst Suing FDA Over Rezurgi Approval
- URL: https://www.fdaweb.com/catalyst-suing-fda-over-rezurgi-approval/
- Published: 2019-06-12T12:00:00.000Z
- Updated: 2026-09-15T01:32:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144316

Catalyst Pharmaceuticals is suing FDA in a Florida federal court, challenging the agency’s recent approval of Jacobus Pharmaceuticals’ Rezurgi for treating Lambert-Eaton Myasthenic Syndrome in pediatric patients. The company [says](invoiceshttps://www.globenewswire.com/news-release/2019/06/12/1867580/0/en/Catalyst-Pharmaceuticals-Files-Federal-Lawsuit-Against-U-S-Food-and-Drug-Administration.html) its suit alleges that the approval violates multiple FDA labeling regulations, resulting in Rezurgi being misbranded. The suit also says FDA violated Catalyst’s statutory rights to orphan drug exclusivity and new chemical entity exclusivity under the Federal Food, Drug, and Cosmetic Act; and was arbitrary, capricious, and contrary to law, in violation of the Administrative Procedure Act. Among other remedies, Catalyst is seeking an order vacating FDA’s approval of Ruzurgi.