August 1, 2008 Approval Letter - Fluvirin
Our STN: BL 103837/5358
August 1, 2008
Novartis Vaccines and Diagnostics Limited
Attn: Lisa Bissett
Liverpool L24 9GR
Dear Ms. Bissett:
We have approved your request to supplement your Biologics License Application for Influenza Vaccine, Fluvirin®, to include the 2008-2009 United States formulation for vaccine produced at the Liverpool, UK--------------------------.
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.
Jerry Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling