Product Approval Information
Proper Name: Influenza Virus Vaccine
Tradename: Fluarix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 145 KB) - August, 2008
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Date: August 4, 2008
New Formulation: 2008-2009 United States formulation
August 5, 2008 Approval Letter
Date: July 24, 2007
New Formulation: 2007-2008 United States formulation
July 24, 2007 Approval Letter
Date: July 25, 2006
New Formulation: 2006-2007 United States formulation
July 25, 2006 Approval Letter
Date: August 31, 2005
Indication: For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B
August 31, 2005 Approval Letter
Clinical Review -
Part 1 (PDF - 1.8 MB),
Part 2 (PDF - 1.7 MB)
Statistical Review (PDF 277 KB)
Talkpaper - FDA Approves New Influenza Vaccine for Upcoming Flu Season - August 31, 2005