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FDA Approves New 3000 IU Vial Size for Kogenate(R) FS, antihemophilic factor (recombinant)
Date:8/7/2009

WAYNE, N.J., Aug. 7 /PRNewswire/ -- Today, Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a 3000 IU (international unit) vial size of Kogenate(R) FS, antihemophilic factor (recombinant). The new vial size offers greater convenience for patients with hemophilia A who require a higher dose.

The 3000 IU vial may eliminate the need for combining smaller vials and may allow some patients to achieve more precise dosing. It is available in a conventional vial-to-vial reconstitution system and in Kogenate FS Grab & Go packaging with BIO-SET(R), a compact and complete reconstitution system. Grab & Go includes the Terumo(R) SURFLO(R) Infusion Set with filter and other materials necessary for safe reconstitution and fast recombinant factor VIII treatment in a small, tamper-evident box with anticounterfeiting features.

"The availability of Kogenate FS in a 3000 IU vial demonstrates Bayer's commitment to adolescent and adult patients, who are more likely to have a need for higher doses and who will appreciate the greater convenience of the larger vial," said Joni Osip, RN, MS, Hemophilia Nurse Coordinator, Center for Bleeding and Clotting Disorders at the University of Minnesota Medical Center, Fairview, in Minneapolis.

The Kogenate FS line of products now includes the following vial sizes: 250, 500, 1000, 2000 and 3000 IU. Kogenate FS has one of the smallest diluent volumes available. The 250, 500 and 1000 IU vial sizes are provided with 2.5 mL of diluent; the 2000 and 3000 IU vial sizes are reconstituted with 5 mL of diluent. The 3000 IU vial size is now part of the Kogenate FS Free Trial Program, which is open to people with hemophilia A who meet program eligibility criteria.

"The 3000 IU vial size is being offered in response to customer needs and
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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