May 16, 2008
Our STN: BL 101069/5172
Merck & Co., Inc.
Attention: Alison Fisher, Ph.D.
P.O. Box 1000
North Wales, PA 19454
Dear Dr. Fisher:
We have approved your request to supplement your biologics license application for Measles, Mumps, and Rubella Virus Vaccine Live, to include epididymitis under Urogenital System in the adverse reactions section of the package insert to reflect reports received during post-marketing surveillance, and to include additional minor editorial changes.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.
We will include information contained in the above-referenced supplement in your biologics license application file.
/Loris D. McVittie, Ph.D./
Loris D. McVittie, Ph.D.
Acting Division 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