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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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

 

Contact FDA

(800) 835-4709
(301) 827-1800
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