Our STN: BL 125284/0
GTC Biotherapeutics, Inc.
Attention: Mr. Richard A Scotland
175 Crossing Boulevard
Framingham , MA 01702
Dear Mr. Scotland:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated January 31, 2008 for Antithrombin alfa to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is February 7, 2009. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than January 9, 2009. If postmarketing study commitments (506B) are required, we will contact you no later than January 9, 2009.
At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-3524.
Acting Division Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research