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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Acknowledgment Letter 2 - 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

Date of Application : January 31, 2008

Date of Receipt : August 8, 2008

We have received your application submitted under provision (c) of Section 506 of the Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Product. We acknowledge your schedule for submission of the remaining portions of this application. In accordance with provision (c) of the act, our review clock will not start until the date on which you submit the final portion and inform us that your application is complete.

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

If you have any questions, please contact me at (301) 827-6124 .

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