Vaccines, Blood & Biologics
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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
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.
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Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling