Product Approval Information - Licensing Action

January 30, 2007

Our STN: BL 103239/5109

GlaxoSmithKline Biologicals
Attention: Arthur Berger, Jr.
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Mr. Berger:

We have approved your request to supplement your biologics license application for Hepatitis B (Recombinant) Vaccine (ENGERIX-B®), to include thimerosal-free formulation with a hold time of --------- for the bulk, testing of the thimerosal-free product with the GSK Hepatitis B ---------------------, ------------------- Hepatitis B, and extension of the expiry of the thimerosal-free product in final containers to 36 months.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

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

Sincerely yours,

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

CBER Information

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