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Vaccines, Blood & Biologics

March 28, 2000 Approval Letter - Engerix-B

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

March, 28, 2000

Our Reference Number: 99-1110

Johan Van Hoof, M.D.
SmithKline Beecham Biologicals
Rue de l'institut 89
R-1330 Rixensart

Dear Dr. Van Hoof:

The supplement to your License Application for Hepatitis B Vaccine (Recombinant) to include a preservative-free pediatric monodose presentation has been approved.

Under this approval the dating period shall be 24 months from the date of manufacture when stored continuously at 2-8°C. The date of manufacture shall be defined as the date of initiation of the last valid potency test on the final container product. As stipulated in the approval letter of January 12, 1994, Alternatives to Lot Release will remain in effect for the preservative-free presentation.

Regarding your stability protocol, we acknowledge your commitment of March 23, 2000 to accumulate real time stability data at the following intervals (0, 3, 6, 9, 12, 18, 24, 30 and 36 months). In vivo potency testing will be done at each time interval for 3 lots of vials and 3 lots of syringes. In vitro potency testing will be done on these 6 lots plus 2 additional vial lots and 2 additional syringe lots.

We also acknowledge your commitment to submit these stability data to CBER as they are collected, concurrent with each testing timeframe.

This information will be included in your License Application file.

Please submit three copies of final printed labeling, under label review number 1999023001, at the time of use and include Part II of the label transmittal form with completed implementation information.

Sincerely yours,
  --- signature ---

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

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