Product Approval Information
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: ReFacto
Manufacturer: Genetics Institute, Inc, License #1163
Package Insert (PDF - 1 MB) - March, 2000
Date: March 6, 2000
Indication: Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A
March 6, 2000 Approval Letter
Summary of Basis for Approval (PDF - 950 KB)