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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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RAC Letter

 

Our STN: BL 125389/0
 
Biotest Pharmaceuticals Corporation
Attention: Gary Ingenito, Ph.D.
5800 Park of Commerce Blvd., N.W.
Boca Raton, FL 33487
 
Dear Dr. Ingenito:
 
 
We have received your October 25, 2012 resubmission to your biologics license application for Immune Globulin Intravenous (Human) on October 26, 2012.
 
The resubmission contains additional CMC information that you submitted in response to our August 6, 2012 complete response letter. 
 
We consider this a complete, class 1 response to our action letter. Therefore, the user fee goal date is December 26, 2012.
 
If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at 827-6124.
 
Sincerely yours,
 
 /s/
 
Iliana Valencia
Branch Chief,
Regulatory Project Management Branch
Office of Blood Research and Review
Center for Biologics
   Evaluation and Research