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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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June 3, 2009 Approval Letter - Varivax

Our Submission Tracking Number (STN): BL 103552/5356

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 include use of a Patient Package Insert.

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

 

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