Our STN: BL 103239/5305
Attention: Byron Bravo
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Mr. Bravo:
We have received your July 26, 2010, supplement to your biologics license application for Hepatitis B Vaccine (Recombinant), Engerix-B®, to revise the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
Your submission is in the form of a "Special Labeling Supplement – Changes Being Effected" as described under 21 CFR 601.12(f)(2).
This Supplement has been reviewed under STN 103239/5305 and is approved effective this date.
We acknowledge your commitment in your email dated August 13, 2010, that the agreed upon Dear Health Care Provider letter explaining discrepancies in the labeling regarding latex statements will be included with shipments of the pre-filled syringe cartons of Engerix-B® which bear these labeling discrepancies.
Please submit all final printed labeling at the time of use and include implementation information on Forms FDA 356h. Provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling