
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
