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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

November 10, 2009 Approval Letter - Afluria/Influenza A (H1N1) 2009 Monovalent

November 10, 2009

Our STN: BL 125254/132

CSL Limited
Attention: Paul Hartmann, R.Ph.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA 19406-0901

Dear Mr. Hartmann:

We have approved your request to supplement your biologics license application (BLA) for Influenza Virus Vaccine, Afluria®, to include active immunization against influenza for individuals 6 months through 17 of age and to include the data from pediatric clinical studies with revision of the prescribing information for Afluria®. Under this approval, we are also approving a new presentation of 0.25 ml dose prefilled syringes.

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.

Please note that the accelerated approval regulation concerning promotional materials (21 CFR 601.45) stipulates that promotional items intended for dissemination after the first 120 days following initial BLA approval should be submitted to the FDA 30 days prior to the anticipated distribution date. Please 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,

/signature/

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