Our STN: BL 125248/0
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.
/Basil Golding, M.D./
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research