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Proper Name
Influenza Virus Vaccine
For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.

FLUARIX, Influenza Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension.

Key Regulatory Milestones

08/31/2005 - approved under accelerated approval regulations 

10/2/2009 - ‘traditional approval’  granted

10/19/2009 - Expansion of the age indication approved.

12/14/2012 - Fluarix Quadrivalent was approved

08/28/2013 - Type C meeting briefing package submitted 

03/11/2014 - In pre-BLA Type C meeting held 

11/18/2016 - FDA approval date

11/20/2016 - PDUFA Goal Date

Advisory Committee

A Vaccines and Related Biologics Products Advisory Committee (VRBPAC) meeting was not held for this supplement, as there were no issues or concerns that presented during the course of review of the supplement that required consult from the advisory committee.

Advanced Facts