Catalyst has filed a lawsuit against the U.S. FDA claiming the regulator’s recent approval of a new drug is illegal and should be thrown out. The lawsuit is the latest chapter in a bizarre competition between Catalyst Pharmaceuticals and Jacobus Pharmaceutical, two small biotechs that both have FDA-approved drugs for a rare disease called Lambert-Eaton Myasthenic Syndrome, or LEMS. At the core of Catalysts lawsuit are two claims, the first being that the labeling of the drug from Jacobus is illegal. The second claim being that the the FDA violated the orphan drug exclusivity period by approving a competitor after just a few months had passed. Learn More