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Vaccines, Blood & Biologics

September 23, 1999 Approval Letter - Recombivax HB

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

September 23, 1999

Our Reference Number: 98-1078
Label Review Number: 19980929001

Roberta L. McKee, Ph.D.
Merck & Co., Inc.
Sumneytown Pike
West Point, PA 19486

Dear Dr. McKee:

The Labeling Supplement to your License Application for Hepatitis B (Recombinant) Vaccine, to include the addition of two doses of the 10 mcg formulation (1.0 mL) administered at 0 and 4 to 6 months as an alternate regime for the routine vaccination of healthy adolescents 11 to 15 years of age, has been approved. This information will be included in your License Application file.

Please submit three copies of final printed labeling, under label review number 19980929001, at the time of use and include part II of the label transmittal form with completed implementation information.


Sincerely yours,

--- signature ---

Peter A. Patriarca, M.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

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