STN: BL 101447
Proper Name: Anti-Inhibitor Coagulant Complex
Tradename: FEIBA NF
Manufacturer: Baxter Healthcare Corp
Indicated for use in hemophilia A and B patients with inhibitors for:
- Control and prevention of bleeding episodes
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
December 16, 2013 Approval Letter - FEIBA
To update the FEIBA Package Insert (PI) based on the completed Clinical Study (090701).
December 4, 2013 Summary Basis for Regulatory Action - FEIBA(PDF - 460KB) Clinical Review - FEIBA(PDF - 788KB) February 2, 2011 Approval Letter - FEIBA
Revise to supplement biologics license application.
July 16, 2010 Approval Letter - FEIBA
Revised to add a boxed warning related to thrombotic and thromboembolic events following the infusion of this product.
FDA Online Label Repository
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Dear Healthcare Provider: Risk of thrombotic and thromboembolic events following infusion of FEIBA VH or FEIBA NF(PDF - 39KB)