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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Acknowledgement Letter - Berinert, June 30, 2009

Our STN:  BL 125287/0

CSL Behring GmbH
Attention:  Paul Hartmann, R.Ph.
1020 First Avenue
P.O. Box 61501

King of Prussia, PA  19406-0901


Dear Mr. Hartmann:

 

We have received your April 8, 2009 resubmission to your biologics license application for C1 Esterase Inhibitor (Human) on April 10, 2009.

 

The resubmission contains additional CMC and clinical information that you submitted in response to our December 5, 2008 complete response letter.

 

We consider this a complete, class 2 response to our action letter.  Therefore, the user fee goal date is October 10, 2009.

 

If you have any questions, please contact the Regulatory Project Manager, Nannette Cagungun, at 827-6174.

 

Sincerely yours,

 

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood
  Research and Review
Center for Biologics
  Evaluation and Research