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FDA Approves New Syringe for Pfizer’s XYNTHA®

In August, Pfizer Inc., announced that the U.S. Food and Drug Administration (FDA) granted approval for the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA®, the company’s recombinant factor VIII product. XYNTHA® is indicated for use in patients with hemophilia A to control and prevent bleeding episodes and for surgical prophylaxis.


The device delivers XYNTHA® by intravenous (IV) infusion after reconstitution of a freeze-dried powder with the diluent solution (0.9% sodium chloride). For the first time, both the XYNTHA® powder and the diluent are supplied within the Prefilled Dual-Chamber Syringe. The new system will provide 3,000 international units (IU) of XYNTHA®, the highest dose, in a low 4-milliliter (mL) volume. Other dosages will be available in the new syringe in 2011.


“For the hemophilia A patient who is always on the go, any treatment option that can enhance convenience is critical to the management of his health and lifestyle,” said Sue Geraghty, RN, MBA, Nurse Coordinator, University of Colorado School of Medicine Hemophilia and Thrombosis Center in Aurora.  “As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with hemophilia A convenience in reconstituting XYNTHA®, potentially saving them both time and effort.”


Source: Pfizer news release dated August 9, 2010