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$BAX,...FDA clears Baxter hemophilia A treatment

The FDA approves Baxter International's (NYSE:BAX) Orphan Drug-designated Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder.

Orbizur is the first recombinant procine FVIII treatment approved for AHA that allows physicians to manage treatment by measuring factor VIII activity levels in addition to clinical assessments.

Among the benefits of the Orphan Drug tag is a seven-year period of marketing exclusivity following regulatory approval.