Product Approval Information
Proper Name: Coagulation Factor IX (Recombinant)
Tradename: Benefix
Manufacturer: Wyeth Pharmaceuticals, License #0003
Package Insert (PDF - 156 KB) - July, 2006
Date: July 11, 2006
Revised Package Insert
July 11, 2006 Approval Letter (PDF - 39 KB)
Date: February 11, 1997
Indication: Control and prevention of hemorrhagic episodes in patients with hemophilia B, including the peri-operative management of hemophilia B patients undergoing surgery
February 11, 1997 Approval Letter
Summary of Basis for Approval
New Recombinant Product for Hemophilia B - February 11, 1997