Bayer Biological Products (BP) announced that it received U.S. Food and Drug Administration approval of new storage guidelines for its recombinant factor VIII product, Kogenate FS®. The guidelines, which will appear on all Kogenate FS® packaging starting in November 2005, will allow the product to be stored at room temperature (77 degrees Fahrenheit, 25 degrees Celsius). Although this mode of storage is now an acceptable option, Bayer recommends factor be refrigerated when possible.
“We are pleased with the approval and the opportunity to provide our customers with this convenience. This new labeling will provide greater freedom and allow individuals with hemophilia A to lead full, active and productive lives,” said Terry Tenbrunsel, vice president of sales and marketing for Bayer BP.
Source: Business Wire, October 6, 2005