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Vaccines, Blood & Biologics

Letter - Proprietary Name Review - Prevnar 13

Our STN: BLA 125324

Wyeth Pharmaceuticals, Inc.

Attention: Jack D. Love, Ph.D.
401 N. Middletown Road
Pearl River, NY 10965

Dear Dr. Love:

We have reviewed your submission dated March 31, 2009, to your biologics license application (BLA) for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) requesting a proprietary name review.

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Prevnar 13, is acceptable at this time.

If you have any questions, please contact either Regulatory Project Manager, LCDR Michael Smith, Ph.D., or CDR Colleen Sweeney, M.S., at (301)-827-3070.

Sincerely yours,


Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 09/24/2013
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