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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 27, 2008 Approval Letter - ProQuad

February 27, 2008

OUR STN: BL125108/266

Merck & Co., Inc.
Attention: Michael Dekleva, Ph.D.
UG2D-68
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.

Sincerely yours,

--signature--
Loris D. McVittie, Ph.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

 

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