

 

Filing Letter - Atryn



 
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.

Sincerely yours,

Elizabeth Callaghan
 Acting Division Director
 Division of Blood Applications
 Office of Blood Research and Review
 Center for Biologics Evaluation and Research
 
