The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.