Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

July 23, 2010 Approval Letter - FluLaval

Food and Drug Administration
Rockville, MD 20852-1448

July 23, 2010

Our STN: BL 125163/172

ID Biomedical Corporation of Quebec
Attention: LaDonna Nugent, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Nugent:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine (FluLaval), to include the 2010-2011 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format.

We will include 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

Resources for You

Page Last Updated: 08/03/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.