CPRX - Catalyst gets court's favorable judgement in FDA lawsuit over rival drug approval

Catalyst Pharmaceuticals (CPRX -0.7%) said a District Court entered summary judgment in favor of the company in a lawsuit against the FDA. The District Court's order implements the decision of the U.S. Court of Appeals for the 11th Circuit, which ruled that the U.S FDA's approval of Jacobus Pharmaceutical's medicine Ruzurgi to treat pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) violated Catalyst's exclusivity for FIRDAPSE under the Orphan Drug Act. The company said that as a result of the District Court's order, the FDA marketing approval granted to Ruzurgi is no longer valid. "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," said Catalyst's Chairman and CEO Patrick McEnany.

For further details see:

Catalyst gets court's favorable judgement in FDA lawsuit over rival drug approval