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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 16, 2010 Approval Letter - FEIBA

Our STN: BL 101447/5420                      
 
Baxter Healthcare Corporation
Attention: Dr. Kalpana Chakraburtty
One Baxter Way
Westlake Village, CA 91362
 
Dear Dr. Chakraburtty:
 
This letter supersedes our letter dated March 18, 2010.
 
We have approved your request to supplement your biologics license application (BLA) for Anti-Inhibitor Coagulant Complex, to add a boxed warning related to thrombotic and thromboembolic events following the infusion of this product, and to distribute, according to 21 CFR 200.5, a Dear Healthcare Professional letter to communicate this important drug warning for this product.
 
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Provide content of labeling in Structured Product Labeling format. 
 
You must submit two copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 [21 CFR 601.12(f)(4)]. You may submit two draft copies of proposed advertisement and promotional labeling for advisory comment with Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. 
 
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claims [21 CFR 202.1(e)(6)].
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
 
 /signature/
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research