STN: BL I03677
Proper Name:Coagulation Factor IX (Recombinant)
Manufacturer: Wyeth Pharmaceuticals, License #0003
July 11, 2006 Approval Letter (PDF - 39 KB)(PDF - 39KB)
Revised Package Insert.
February 11, 1997 Approval Letter - Benefix
Indication: Control and prevention of hemorrhagic episodes in patients with hemophilia B, including the peri-operative management of hemophilia B patients undergoing surgery.
Summary of Basis for Approval - Benefix(PDF - 1.2MB)