February 27, 2008
OUR STN: BL125108/266
Merck & Co., Inc.
Attention: Michael Dekleva, Ph.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Dekleva,
We have approved your request to supplement your biologics license application for Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad®), to include revisions to the package insert.
The Adverse Reactions section of the label has been revised to include two adverse events, encephalitis and epididymitis, to reflect updated data from post-marketing surveillance reports. Information regarding the potential risk of febrile seizures following ProQuad® administration has also been added to this section.
Please provide a PDF-format electronic version of all final printed labeling and implementation information at the time of use.
We will include information contained in the above-referenced supplement in your Biologics License Application File.
Loris D. McVittie, 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