STN: BL 103332
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Kogenate FS
Manufacturer: Bayer Corp, License #0008
- Control and prevention of bleeding episodes in adults and children with hemophilia A.
- Peri-operative management in adults and children with hemophilia A.
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
May 9, 2015 Approval Letter - Kogenate FS(PDF - 37KB)
To expand the indication of Kogenate FS to include adult prophylaxis.
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) [ARCHIVED] June 26, 2000 Approval Letter - Kogenate FS[ARCHIVED]
Manufacturing Change: New product formulation
FDA Online Label Repository
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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A[ARCHIVED]
Press Release: 10/10/2008