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FEIBA NF (Anti-Inhibitor Coagulant Complex)
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
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
Dear Healthcare Provider: Risk of thrombotic and thromboembolic events following infusion of FEIBA VH or FEIBA NF(PDF - 39KB)