The U.S. Food and Drug Administration approved Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors. The FDA granted Qfitlia Orphan Drug and Fast Track designations for this application. The FDA granted the approval of Qfitlia to Sanofi (SNY).
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