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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 13, 2010 Approval Letter - Varivax

Our STN: BL 103552/5544

Merck & Co., Inc.                                                                  
Attention: Donna Zacholski                                      
P.O. Box 1000, UG2D-68
North Wales, PA  19454-1099

Dear Ms. Zacholski:

We have approved your request to supplement your biologics license application for Varicella Virus Vaccine Live (VARIVAX®), to update the package insert and Patient Product Information sheets for the liquid and frozen formulations to include changes to the Adverse Reaction and Risk of Vaccine Transmission section.

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.

Sincerely yours,

/signature/
Wellington Sun, MD
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