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Letter - Major Amendment Submission - Prevnar 13
Our STN: BLA 125324/0
Wyeth Pharmaceuticals, Inc.
Attention: Jack D. Love, Ph.D.
401 N. Middletown Road
Pearl River, NY 10965
Dear Dr. Love:
We received your July 23, 2009, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) on July 23, 2009.
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.
Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is December 30, 2009.
If you have any questions, please contact Regulatory Project Manager, Michael Smith, or Colleen Sweeney, 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