The U.S. Food and Drug Administration (FDA) has partially rescinded a pair of supplemental Biologics License Applications (BLAs) the agency had granted, in error, for two recombinant factor IX products, BeneFIX® (Pfizer) and IXINITY (Aptevo). The supplemental BLAs in question were both approved by the FDA in 2020 and represented additional indications that ultimately ran against exclusivity rights of another product.
Background:
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FDA Partially Rescinds Added Indications for Two FIX Products
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