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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

September 15, 2009 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.)

September 15, 2009

Our STN:  BL 103914/5260

Sanofi Pasteur Inc.
Attention: Joseph H. Quinn
Discovery Drive
Swiftwater, PA  19370

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application (BLA) for Influenza Virus Vaccine, to include Influenza A (H1N1) 2009 Monovalent Vaccine.

We acknowledge your commitment in your amendment dated September 10, 2009, to submit results from your clinical studies using this product in populations for which your seasonal influenza vaccine is already licensed, as an efficacy supplement to your BLA for FDA review.   This supplement should also contain updated labeling incorporating these clinical data and should be submitted as soon as possible to the preassigned STN103914/-b(4)- with the descriptor: Supplement Contains Postmarketing Study Commitment - Final Study Report.  Please refer to the February 2006 "Guidance for Industry - Reports on the Status of Postmarketing Study Commitments" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM080569.pdf regarding timing and reporting requirements for postmarketing commitment fulfillment.  Prior to submission of your final study report efficacy supplement, please submit interim clinical data as soon as it is available to your IND -b(4)-.

Please note that the ------------------b(4)---------------------------------- ------------------------------------------------------ -------------------- may not be distributedbefore approval of the supplement for this presentation by the Office of Compliance and Biologics Quality.

Please submit all final printed labeling at the time of use and include implementation information on FDA form 356h.  Please provide PDF-format electronic copies of these labels. 

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

/signature/

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