In keeping with its Drug Competition Action Plan released in 2017, the U.S. FDA finalized two guidances this week focused on the submission and review of generic drugs.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.