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April 5, 2005 Approval Letter - Varivax

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 5, 2005

Submission Tracking Number (STN): BL 103552/5079

David Gutsch, M.D.
Merck & Co., Inc.
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486

Dear Dr. Gutsch:

The Supplement to your Biologics License Application for Varicella Virus Vaccine Live (VARIVAX), to include an optional second dose for children 12 months to 12 years of age, has been approved. This information will be included in your License Application file.

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 note that you have fulfilled the pediatric study requirement for this application.

Sincerely yours,

--signature--

Philip R. Krause, M.D.
Acting Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

 

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