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