September 16, 2009
Our STN: BL 103850/5356
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 A, Inactivated and Hepatitis B (Recombinant) Vaccine, Twinrix®, to include changes to the package insert regarding the possibility of cracked vials or syringes.
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.
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