July 28, 2009 Approval Letter - Zoster

July 28, 2009
Our STN:  BL 125123/424

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 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.
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