Product Approval Information
Our STN: BL 125264/0
Wyeth Pharmaceuticals, Inc.
Attention: Joyce Schwenk
P.O. Box 8299
Philadelphia, PA 19101-8299
Dear Ms. Schwenk:
This letter is in regard to your proposed proprietary names for Antihemophilic Factor (Recombinant), Plasma/Albumin-Free "Xyntha" received on September 26, 2007.
We have considered your proposed proprietary name, "Xyntha" in consultation with CBER's Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201, the proposed proprietary name "Xyntha" be found acceptable.
If you have any questions, please contact Pauline Cottrell, at (301) 827-6162.
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