November 18, 2008 Approval Letter - Zostavax

November 18, 2008

Our STN: BL 125123/329

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 package inserts for the frozen and refrigerated formulations. The changes consisted of updates to the Post-Marketing Section with the addition of “rash” based on post-marketing reports, reinserting the word “sterile” to Section 11 (Description) of the label, and replacing “lyophilized preparation” with “suspension” in the Highlights section of the label.

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