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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 21, 2006 Approval Letter - Havrix

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

February 21, 2006

Our STN: BL 103475/5100

GlaxoSmithKline Biologicals
Attn: Ms. Judith Magner
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Magner:

We have approved your request to supplement your biologics license application for Hepatitis A Vaccine Inactivated to include the package insert labeling changes regarding geriatric use.

We will include information contained in the above-referenced supplement in your biologics license application file.

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 one original paper copy.

Sincerely yours,

--- signature ---

Karen L. Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

 

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