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Bayer Receives FDA Approval for Kogenate FS® with BIO-SET®

Bayer Biological Products has announced that the U.S. Food and Drug Administration (FDA) approved a new reconstitution system for its recombinant factor VIII product Kogenate® FS. This system utilizes BIO-SET®, a self-contained, needleless reconstitution process that eliminates the risk of accidental needle-stick injuries.

BIO-SET® improves upon having to mix factor from vial-to-vial, by providing a pre-filled syringe, fewer component parts and no exposed needles during reconstitution. Kogenate® FS with BIO-SET® promises to add greater safety and expediency to the routine of infusion for hemophilia patients.

“Kogenate® FS with BIO-SET® is a treatment option that will fit well into the lives of our patients. With fewer components, fewer steps in the reconstitution process, and fewer exposed needles, Kogenate® FS with BIO-SET® will provide patients with a safe, convenient way to prepare their hemophilia treatment,” said Regina Butler, RN, hemophilia nurse coordinator at the Children’s Hospital of Philadelphia.

Source: Bayer news release dated November 28, 2005


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