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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 30, 2008 Approval Letter - Varivax

Our Submission Tracking Number (STN): BL 103552/5276

October 30, 2008

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 frozen and refrigerated formulations of Varicella Virus Vaccine Live (VARIVAX) to remove the phrase “(Oka/Merck)” from the generic name on the product carton and container labeling and from within the package insert. In addition we approve your revisions to the package insert to clarify the statement regarding anaphylaxis.

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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