October 19, 2009 Approval Letter - Fluarix

October 19, 2009

Our STN: BL 125127/319
GlaxoSmithKline Biologicals
Attention: Judith Magner
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, PA  19406-2772

Dear Ms. Magner:

We have approved your request to supplement your biologics license application (BLA) for Influenza Virus Vaccine, Fluarix®, to include expanded indication for active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information for Fluarix® .  

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.

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.

If you have any questions, please contact Dr. Sara Gagneten, Regulatory Project Manager, at (301) 827-3070.                            

Sincerely yours,

 

Wellington Sun, M.D.
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