Product Approval Information - Licensing Action
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,
/Loris McVittie/
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