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Vaccines, Blood & Biologics

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
UG2D-68
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.

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

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