• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448