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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name 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 proposed proprietary names for Thrombin (Recombinant), "RECOTHROM" and "----
-------------", received on April 30, 2007.

We have considered your proposed names "RECOTHROM" and "------------------" in consultation with CBER's Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201, the proposed proprietary name "RECOTHROM" is acceptable and "------------------" is not acceptable.

If you have any questions, please contact the Regulatory Project Manager, Mark A. Shields at (301) 827-6173.

Sincerely yours,

/Basil Golding, M.D./
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

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Office of Communication, Outreach and Development

Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448