Bayer HealthCare has announced the FDA approval of their 3000 IU (international unit) vial size of Kogenate FS (recombinant antihemophilic Factor VIII). This new vial size offers greater convenience for patients who require a higher dose. The 3000 IU vial may also eliminate the need for combining smaller vials and 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, a compact and complete reconstitution system.

Kogenate FS is approved for the prevention and control of hemorrhagic episodes and perioperative management in adults and children with Hemophilia A.  It is also indicated for routine prophylaxis to reduce frequency of hemorrhagic episodes and the risk of joint damage in children with Hemophilia A with no pre-existing joint damage.

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