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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Letter - Bivigam

 

Our STN: BL 125389/0
 
Biotest Pharmaceuticals Corporation
Attention: Mr. Matthew Vaughn
5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
 
Dear Mr. Vaughn:
 
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
 
We have completed an initial review of your application dated November 3, 2010 for Immune Globulin Intravenous (Human) to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is September 3, 2011. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 
 
We will contact you regarding your proposed labeling no later than August 4, 2011. If postmarketing study commitments (506B) are required, we will contact you no later than August 4, 2011.
 
At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
 
If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-6124.
 
Sincerely yours,
 
 /s/
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
 Management Branch
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research