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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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April 30, 2008 Approval Letter - RotaTeq

April 30, 2008

Our Submission Tracking Number (STN): BL 125122/443

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 received your April 14, 2008, Supplement to your Biologics License Application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq®. The patient package insert has also been updated to include this information.

This Supplement has been reviewed under STN 125122/443 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.

This information will be included in your License Application File.

Sincerely yours,

--signature--

Loris D. McVittie, Ph.D.
Acting Director
Viral Vaccine Branch
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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