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
