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Vaccines, Blood & Biologics

February 27, 2008 Approval Letter - ProQuad

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.

Sincerely yours,

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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 11/03/2009
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