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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 28, 2007 Approval Letter - RotaTeq

September 28, 2007

Our Submission Tracking Number (STN): BL 125122/201

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

Dear Dr. Howard:

We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include the addition of G9 P1A[8] serotype case reduction in the "Clinical Studeis" seciton of the package insert, and revision of the label in the Physician's Labeling Rule format.

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

Sincerely yours,

--signature--

Janice M. Soreth, M.D.
Acting 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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