Product Approval Information
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