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Pfizer Receives FDA Approval for Prefilled Dual-Chamber Syringe for Use in the Treatment of Hemophilia A
 

                              -----New, Innovative Device for the Hemophilia Community
    NEW YORK, Aug. 9 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand‘s disease.
    "The approval of the Prefilled Dual-Chamber Syringe is an important milestone for hemophilia patients due to its innovative, convenient reconstitution system that eliminates the transfer step," said Emil Andrusko, vice president, marketing, Specialty Biologics at Pfizer Inc. "Pfizer is committed to the hemophilia community not only through the development of novel reconstitution systems focusing on convenience, such as the XYNTHA Prefilled Dual-Chamber Syringe, but also through early clinical research of other proteins, including Factor Xa and Factor VIIa."


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