Catalyst Loses NDA Lawsuit Against FDA

Catalyst Pharmaceuticals says that a Florida magistrate judge has ruled in favor of FDA in the company’s lawsuit against the agency for approving competitor Jacobus Pharmaceutical’s Ruzurgi (amifampridine) for treating the rare disorder Lambert-Eaton Myasthenic Syndrome. Catalyst had argued that its orphan drug exclusivity on a competing product, Firdapse (amifampridine), should have blocked Jacobus from gaining approval for Ruzurgi (see earlier story).

Catalyst says that the magistrate judge considering Catalyst’s lawsuit has recommended to a southern Florida judge handling the case that the court “grant the FDA's and Jacobus’ motions for summary judgment and deny Catalyst's motion for summary judgment.” The company says it is currently reviewing the magistrate judge’s decision, which it believes to be incorrect as a matter of law, and intends to pursue the case further with the district judge.