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Vaccines, Blood & Biologics

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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)

  • (800) 835-4709
  • (301) 827-1800
  • 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

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