The FDA approved the storage labeling change based on data from testing to assure the labeled potency remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for Kogenate FS users.
Starting in November 2005, each package of Kogenate FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, Bayer recommends refrigerating Kogenate FS whenever possible.
“We are pleased with the approval and the opportunity to provide our customers with this convenience,” said Terry Tenbrunsel, vice president of sales and marketing at Bayer BP.