Vaccines, Blood & Biologics

Resources for You

STN: BL I03677
Proper Name:Coagulation Factor IX (Recombinant)
Tradename: Benefix
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)

(800) 835-4709

(301) 827-1800

Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448