Vaccines, Blood & Biologics
Kogenate FS
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Kogenate FS
Manufacturer: Bayer Corp, License #0008
Package Insert (PDF - 286 KB) - October 2008
Date: October 10, 2008
Revise Indications for Use: To include routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children.
October 10, 2008 Approval Letter
Final review memo (PDF - 396 KB)
Press Release: FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Date: June 26, 2000
Manufacturing Change: New product formulation
June 26, 2000 Approval Letter
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