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Vaccines, Blood & Biologics

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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/12/2015
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