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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Acknowledgment Letter 1 - Atryn

GTC Biotherapeutics, Inc.
Attention: Mr. Richard A Scotland
175 Crossing Boulevard
Framingham , MA 01702

Dear Mr. Scotland:

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 125284/0

Name of Biological Product : Antithrombin alfa

Indication : For the prevention and treatment of thromboembolic events

Review Priority Classification : Priority (P)

Date of Application : January 31, 2008

Date of Receipt : August 8, 2008

Action Due Date: February 7, 2009:

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 Application, HFM-370
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) 827-3524.

Sincerely yours,

Pratibha Rana, M.S.
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research