July 17, 2009
Our STN: BL 103837/5503
Novartis Vaccines and Diagnostics Limited
Attention: Joanne Totosy de Zepetnek, PhD
350 Massachusetts Avenue
Cambridge, MA 02139
Dear Dr. Totosy de Zepetnek:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, to include the 2009-2010 United States formulation.
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 information contained in the above-referenced supplement in your biologics license application file.
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