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Vaccines, Blood & Biologics

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
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,


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

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: 02/26/2010
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