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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 28, 2009 Approval Letter - Zostavax

July 28, 2009
Our STN:  BL 125123/424

Merck & Co., Inc.
Attention:  Alison Fisher, Ph.D.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099

Dear Dr. Fisher:

We have approved your request to supplement your biologics license application for Zoster Vaccine Live, to include changes to the adverse reactions and post-marketing experience sections of the package insert (Section 6.2) as well as changes to the patient package circular regarding “transient injection-site lymphadenopathy”.

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--

Wellington Sun, M.D.
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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