Our STN: BL 125324/0
Wyeth Pharmaceuticals, Inc.
Attention: Jack D. Love, Ph.D.
401 N. Middletown Road
Pearl River, NY 10965
Dear Dr. Love:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated March 31, 2009, for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is September 30, 2009. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than September 2, 2009. If post marketing study commitments (506B) are required, we will contact you no later than September 2, 2009.
While conducting our filing review, we identified potential review issues and will be communicating them to you on or before June 13, 2009.
If you have any questions, please contact either Regulatory Project Manager, LCDR Mike Smith, Ph.D., or CDR Colleen Sweeney MS, 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