
Amendment Acknowledgment Letter - RECOTHROM


 

 
Our STN: BL 125248/0

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

Dear Mr. Gauthier:

We received your July 31, 2007 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for Thrombin (Recombinant) on August 1, 2007.

We consider your submission a major amendment under the Prescription Drug User Fee Act of 1992.

Because we received this major amendment within three months of the action due date on this application we will add an additional three months to the time by which we should complete our review. Therefore, the goal date is January 17, 2008.

If you have any questions, please contact the Regulatory Project Manager, Mark 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
