RAC Letter - Bivigam



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 