In a regulatory filing, on March 14, Apellis Pharmaceuticals announced it received notification from the U.S. FDA that the FDA is extending the Prescription Drug User Fee Act goal date for the supplemental New Drug Application for the Empaveli Injector. The FDA stated in writing that, "the labeling is still under review at this time and the FDA will miss the goal date of March 15, 2023" The timing of the new PDUFA goal date is still being determined. The Empaveli Injector is an on-body device designed to enhance self-administration of Empaveli, which is approved for adults with paroxysmal nocturnal hemoglobinuria.
Published first on TheFly
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