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March 30, 2010 Approval Letter - Zostavax
March 30, 2010
Our STN: BL 125123/654
Merck & Co., Inc.
Attention: Alison Fisher, Ph.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Fisher:
We have received your December 10, 2009, labeling supplement to your biologics license application for Zoster Vaccine Live, Zostavax®, to include the following changes to the package insert:
- Update instructions for reconstitution of the vaccine in Section 2.2 Preparation for Administration, and
- Minor editorial correction in Section 6.1.2 VZV Rashes Following Vaccination.
This Supplement has been reviewed under STN 125123/654 and is approved effective this date.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
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.
This information will be included in your License Application File.
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