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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 16, 2009 Approval Letter - Twinrix

September 16, 2009

Our STN:  BL 103850/5356

GlaxoSmithKline Biologicals
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.   

Sincerely yours,


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