
Filing Notification Letter - RECOTHROM


 

 
Our STN: BL 125248/0

ZymoGenetics, Inc.
 Attention: Mr. Mark W Gauthier
 1201 Eastlake Avenue East
 Seattle, WA 98102

Dear Mr. Gauthier:

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 December 15, 2006 for Thrombin (Recombinant) to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is October 18, 2007. 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.

While conducting our filing review, we identified potential review issues and will be communicating them to you on or before March 2, 2007.

Should you need additional information or have any questions concerning administrative or procedural matters please contact the Regulatory Project Manager, Mark A. Shields at (301) 827-6173.

Sincerely yours,

/Alan Williams, Ph.D./
 Alan Williams, Ph.D.
 Director
 Division of Blood Applications
 Office of Blood Research and Review
 Center for Biologics Evaluation and Research
