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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Resources for You

June 18, 2008 Approval Letter - Zostavax (Frozen)

June 18, 2008

Our STN: BL 125123/298

Merck & Co., Inc.
Attention: Laurie MacDonald, M.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099

Dear Dr. MacDonald:

We have approved your request to supplement your biologics license application for Zoster Vaccine Live, to include changes to the package insert and patient product information for the frozen formulation.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

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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