Our STN: BLA 125324
Wyeth Pharmaceuticals, Inc.
Attention: Jack D. Love, Ph.D.
401 N. Middletown Road
Pearl River, NY 10965
Dear Dr. Love:
We have reviewed your submission dated March 31, 2009, to your biologics license application (BLA) for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) requesting a proprietary name review.
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Prevnar 13, is acceptable at this time.
If you have any questions, please contact either Regulatory Project Manager, LCDR Michael Smith, Ph.D., or CDR Colleen Sweeney, M.S., at (301)-827-3070.
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research