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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Acknowledgment Letter - Berinert, March 17, 2008

March 17, 2008

CSL Behring LLC

Attention:  Paul Hartmann, R.Ph.

1020 First Avenue

King of Prussia, PA 19406-0901

Dear Mr. Hartmann:

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:

Our Submission Tracking Number (STN):  BL 125287/0

Name of Biological Product:  C1 Esterase Inhibitor Human (C1-INH)

Indication:  Treatment of acute attacks of hereditary angioedema (HAE).

Date of Application:  6 March 2008

Date of Receipt:  7 March 2008

We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number.  Send all correspondence to the following address:

 

Director
Division of Blood Applications
Office of Blood Research and Review
DCC, Suite 200N, HFM-99
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.

If you have any questions, please contact the Regulatory Project Manager, Ms. Nannette Cagungun, at (301) 827-6174.

 

Sincerely yours,

 

Nannette Cagungun, M.S., P.D.  
Regulatory Project Manager 
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research