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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BLA Acknowledgement Letter - CINRYZE

Our STN: BL 125267/0

Lev Pharmaceuticals, Inc.
Attention: Mr. Jason Bablak
675 Third Avenue
Suite 2200
New York , NY 10017

Dear Mr. Bablak :

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 125267/0

Name of Biological Product : C1 Esterase Inhibitor (Human)

Indication : Treatment for acute attacks of hereditary angioedema

Date of Application : July 31, 2007

Date of Receipt : July 31, 2007

Action Due Date : May 30, 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 me at (301) 827-6174.

Sincerely yours,

--signature--

Nannette Cagungun
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research