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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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June 15, 2007 Approval Letter - RotaTeq

June 15, 2007

Our Submission Tracking Number (STN): BL 125122/316

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

Dear Dr. Howard:

We have received your June 8, 2007, Supplement to your Biologics License Application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include changes to the package insert regarding Kawasaki Disease.

This Supplement has been reviewed under STN 125122/316 and is approved effective this date.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy. Under 21 CFR 201.57(f)(2), patient labeling must be reprinted at the end of the package insert and printed in a minimum of 10-point font.

This information will be included in your License Application File.

Sincerely yours,

--signature--

Paul G. Richman, Ph.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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