January 30, 2007
Our STN: BL 103239/5109
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.
Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling