Product Approval Information - Licensing Action
July 6, 2007
Our STN: BL 125123/90
Merck & Co., Inc.
Attn: David E. Gutsch, M.D.
Director, Worldwide Regulatory Affairs, Vaccines/Biologics
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
Dear Dr. Gutsch:
We have approved your request to supplement your biologics license application for Zoster Vaccine Live, to include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine.
Under the Pediatric Research Equity Act (PREA), all applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving pediatric studies for ZOSTAVAX as this vaccine is indicated for individuals > 60 years of age.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
--- signature ---
Paul G. Richman, Ph.D.
Acting 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