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FDA Approves Longer Storage for Bayer’s Kogenate® FS

In April, Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Kogenate® FS, a recombinant factor VIII therapy, for storage at room temperature (up to 77 degrees F) for up to one year. Kogenate® FS is indicated for the treatment of hemophilia A. The previous storage time at room temperature was three months.


“As convenience with medication is important to people with hemophilia A, we're pleased to offer a new storage temperature option, which complements other convenience features, including Grab and Go packaging with BIO-SET®, a compact and complete reconstitution system for Kogenate® FS,” said Paul Bedard, Vice President/General Manager, Hematology, Bayer HealthCare Pharmaceuticals. “This new option demonstrates Bayer's ongoing commitment to the hemophilia A community.”


Source: PRNewswire, April 25, 2011