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September 15, 2009 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited)

September 15, 2009

Our STN:  BL 103837/5514

Novartis Vaccines and Diagnostics Limited
Attention: Joanne Totosy de Zepetnek, Ph.D.
350 Massachusetts Avenue
Cambridge, MA 02139

Dear Dr. Totosy de Zepetnek:

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

We acknowledge your commitment in your cover letter dated August 13, 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 STN 103837/-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 submit final printed labeling at the time of use and include completed 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,


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


Attachment:    Approved Final Draft Labeling

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