June 15, 2007
Our Submission Tracking Number (STN): BL 125122/316
Merck & Co., Inc.
Attention: Angela Howard
P.O. Box 1000
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.
Paul G. Richman, Ph.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling