BERKELEY, Calif.--(BUSINESS WIRE)--Nov. 28, 2005--The Biological Products division of Bayer HealthCare LLC (Bayer BP) announced today that Kogenate(R) FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose) with BIO-SET(R) has been approved by the United States Food and Drug Administration (FDA). Kogenate(R) FS with BIO-SET(R) becomes the first integrated reconstitution system for recombinant factor VIII that eliminates the risk of accidental needle-stick injuries during reconstitution.