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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 28, 2007 Approval Letter - Twinrix

March 28, 2007

Our Submission Tracking Number: BL 103850/5162

GlaxoSmithKline Biologicals
Attention: Ms. 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 & Hepatitis B (Recombinant) Vaccine, to include changes to the package insert for an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose.

All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens must contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving the pediatric study requirement for this application.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

Paul G. Richman, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

 

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