D.C. Federal Judge Punts Challenge To Generic Drug Approval Until FDA Ruling

(September 19, 2024, 8:21 AM EDT) -- WASHINGTON, D.C. — A District of Columbia federal judge partially granted a motion to dismiss a suit filed by a pharmaceutical company against the U.S. Food and Drug Administration challenging the agency’s “bioequivalence determination” of a competitor’s generic drug by ruling that the FDA must first rule on the drugmaker’s citizen petition....