BeneFIX

STN: BL 103677
Proper Name:Coagulation Factor IX (Recombinant)
Tradename: BeneFIX
Manufacturer: Wyeth Pharmaceuticals LLC
Indication:

BeneFIX is a recombinant human blood coagulation factor IX indicated for the treatment of:

• Adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
• Adults with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Product Information

• Package Insert - BeneFIX

Supporting Documents

• February 17, 2021 Partial Rescission of Approval - BeneFIX
• June 26, 2020 Approval Letter - BeneFIX
• Supporting Documents older than three years - BeneFIX