Bayer receives FDA approval for Kogenate FS with Bio-Set for hemophilia

New York, Nov. 28 - Bayer HealthCare LLC said the Food and Drug Administration has approved Kogenate FS with Bio-Set, the first integrated reconstitution system for recombinant factor VIII that eliminates the risk of accidental needle-stick injuries during reconstitution.

"By offering improved safety from needle-stick injuries, proven efficacy, and ease of use, Kogenate FS with Bio-Set is a major advance in hemophilia care" said Terry Tenbrunsel, vice president, sales and marketing at Bayer Biological Products, in a news release. "This is a significant milestone for us at Bayer BP, as it represents the next step in our efforts to advance hemophilia care by providing products and services that improve patient convenience and quality of life."

Bio-Set will be available for hemophilia in the United States in early 2006.

The FDA also recently approved labeling amendments allowing room temperature storage for Kogenate FS. Kogenate FS with Bio-Set can be stored at 77°F for up to three months.

Bayer HealthCare is a subsidiary of Leverkusen, Germany-based pharmaceutical company Bayer AG.

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