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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 9, 2010 Approval Letter - Prevnar 13

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

Our STN: BL 125324/38

Wyeth Pharmaceuticals Inc.
Attention: Ms. Kathleen Kofsky
401 N. Middletown Road
Pearl River, NY 10965

Dear Ms. Kofsky:

We have approved your request to supplement your biologics license application for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar 13®, to include revised specifications for -------------(b)(4)----------------------------------------------------.

This fulfills your non-clinical commitments noted in the February 24, 2010 approval letter, which are described in section 1 of your February 10, 2010, and in the February 18, 2010, amendments to the license application. The commitments fulfilled are the following: -----------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

 

Jay E. Slater, M.D.
Acting Director
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research