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Baxter Int'l (BAX) Reports FDA Approval of OBIZUR as AHA-Related Bleeding Episode Treatment

October 24, 2014 9:04 AM EDT

Baxter Int'l (NYSE: BAX) announced that the United States Food and Drug Administration (FDA) has approved 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. OBIZUR was granted orphan-drug status by the FDA and its review was prioritized based on AHAs classification as a rare disease and the potential for the treatment to address an important unmet medical need.

OBIZUR is the first recombinant porcine FVIII treatment approved for AHA that allows... More