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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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November 16, 2009 Approval Letter - Zostavax

November 16, 2009

Our STN:  BL 125123/461

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, Zostavax®, to include changes to the adverse reactions and post-marketing experience section of the package insert (Section 6.2) as well as changes to the patient package insert, regarding injection-site rash, injection-site urticaria, arthralgia and myalgia.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide content of labeling in Structured Product Labeling format. 

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 Vaccine Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

 

Contact FDA

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