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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 29, 2010 Approval Letter - Fluarix

Our STN:  BL 125127/432                

GlaxoSmithKline Biologicals
Attention:  LaDonna Nugent, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Nugent:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine Fluarix®, to include the 2010-2011 United States formulation.

We acknowledge your commitment in your July 26, 2010, submission that the agreed upon Dear Health Care Provider letter explaining discrepancies in the labeling regarding latex statements will be included in shipments of the pre-filled syringe cartons of Fluarix® which bear these labeling discrepancies. 

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h.  Please provide content of labeling in Structured Product Labeling format.  Please provide carton and container labeling in Structured Product Labeling format.

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

Sincerely yours,

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling

Concurrence Page

Application Number:  BLA 125127/432

Letter Type:    Approval (AP)