• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

?
-

Resources for You

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
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 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.

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448