Vaccines, Blood & Biologics
July 24, 2007 Approval Letter - Fluvirin
Our STN: BL 103837/5240
July 24, 2007
Novartis Vaccines and Diagnostics Limited
Attn: Ms. Lisa Bissett
Gaskill Road, Speke
Liverpool L24 9GR
Dear Ms. Bissett:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Fluvirin®, to include the 2007-2008 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file.
Please submit four copies of final printed labeling at the time of use with completed implementation information.
--- signature ---
Jerry Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Final Draft Labeling of Package Insert, Carton, and Container