
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.

Sincerely yours,

--signature--

Wellington Sun, M.D.

Director
 Division of Vaccines and Related Products Applications
 Office of Vaccines Research and Review
 Center for Biologics Evaluation and Research
