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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 5, 2009 Approval Letter - RotaTeq

February 5, 2009

Our STN: BL 125122/524

Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099

Dear Dr. Koser:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, RotaTeq®, to update the Patient Product Information and Prescribing Information.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

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

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

Attachment: Approved Final Draft Labeling

 

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