Vaccines, Blood & Biologics
Benefix
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
Press Release: New Recombinant Product for Hemophilia B - February 11, 1997
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Consumer Affairs Branch (CBER)
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Food and Drug Administration
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