Product Approval Information - Licensing Action
September 28, 2007
Our Submission Tracking Number (STN): BL 125122/201
Merck & Co., Inc.
Attention: Angela L. Howard, Ph.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
Dear Dr. Howard:
We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include the addition of G9 P1A[8] serotype case reduction in the "Clinical Studeis" seciton of the package insert, and revision of the label in the Physician's Labeling Rule format.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
--- signature ---
Janice M. Soreth, M.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling