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.
Loris D. McVittie, Ph.D.
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