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STN: BL 103332
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Kogenate FS
Manufacturer: Bayer Corp, License #0008
- To include routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children.
March 18, 2010 Approval Letter - Kogenate FS
Revised: To request an increase of non-refrigerated storage temperature.
October 10, 2008 Approval Letter - Kogenate FS
Revise Indications for Use: To include routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children.
Final Review Memo - Kogenate FS(PDF - 547KB) June 26, 2000 Approval Letter - Kogenate FS
Manufacturing Change: New product formulation
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A[ARCHIVED]
Press Release: 10/10/2008