December 23, 2009
Our STN: BL 103239/5272
Attention: Wendy A. Valinski
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Valinski:
We have approved your request to supplement your biologics license application for Hepatitis B Vaccine (Recombinant), Engerix-B®, to update the Package Insert to include the addition of text to visually inspect vials or syringes for cracks prior to administration.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please 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 or substantial clinical experience to support such claims [21 CFR 202.1(e)(6)].
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