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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 18, 2009 Approval Letter - Zostavax

Our STN:  BL 125123/430

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 Highlights, the Drug Interactions (Section 7.1), and the Clinical Studies (Section 14) sections of the package insert; and to the patient package insert.  The revised package insert includes the statement:  ZOSTAVAX and PNEUMOVAX® 23 should not be given concurrently because concomitant use resulted in reduced immunogenicity of ZOSTAVAX.

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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