Catalyst Pharmaceuticals Files Federal Lawsuit Against U.S. Food and Drug Administration
Catalyst Pharmaceuticals, Inc. (CPRX)
Last catalyst pharmaceuticals, inc. earnings: 3/16 05:26 pm
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Source: GlobeNewswire
CORAL GABLES, Fla., June 12, 2019 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), today announced it has filed a suit against the U.S. Food and Drug Administration (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 today 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 Admini
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CPRX
Earnings
- 11/6/24 - Beat
CPRX
Sec Filings
- 11/15/24 - Form 4
- 11/14/24 - Form 144
- 11/14/24 - Form SC
- CPRX's page on the SEC website