Acknowledgment Letter - XYNTHA


Wyeth Pharmaceuticals, Inc
 Attention: Joyce Schwenk
 P.O. Box 2899
 Philadelphia, PA 19101-2899

Dear Ms. Schwenk:

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:

Our Submission Tracking Number (STN): BL 125264/0

Name of Biological Product: Antihemophilic Factor (Recombinant), Plasma/Albumin-free

Indication: To eliminate the use of animal-and human-derived proteins resulting in the development of the ReFacto AF manufacturing process.

Date of Application: 25- April-2007

Date of Receipt: 25-Apr-2007

Action Due Date: 22-Feb-2008

US License Number: 0003

Please submit all future correspondence, supporting data, or labeling relating to this supplement in triplicate, citing the above STN number. Send all correspondence to the following address:

Alan E. Williams, Ph.D.
 Director Division of Blood Applications, HFM-370
 Center for Biologics Evaluation and Research
 Food and Drug Administration
 Suite 200N
 1401 Rockville Pike
 Rockville, MD 20852-1448

This acknowledgment does not mean that this application has been approved, nor does it represent any evaluation of the adequacy of the data submitted. Following a review of this submission, we will advise you in writing as to what action has been taken and request additional information if needed.

If you have any questions, please contact Pauline Cottrell, Regulatory Project Manager, at (301)827-6162.

Sincerely yours,

/Pauline Cottrell, B.S. M.T., ASCP./
 Pauline Cottrell, B.S. M.T., ASCP.
 Regulatory Project Manager
 Regulatory Project Management Branch
 Division of Blood Applications
 Office of Blood Research and Review
 Center for Biologics Evaluation and Research
