Vaccines, Blood & Biologics

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
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,


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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/16/2010
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