September 12, 2007 Approval Letter - FluLaval
Our STN: BL 125163/39
ID Biomedical Corporation of Maryland
Attn: Jane L. Halpern, Ph.D.
Director, Regulatory Affairs
6996 Columbia Gateway Drive, Suite 103
Columbia, MD 21046-3303
Dear Dr. Halpern:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, FluLaval, 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