February 5, 2009
Our STN: BL 125122/524
Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Koser:
We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, RotaTeq®, to update the Patient Product Information and Prescribing Information.
Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.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