Fluarix
FLUARIX, Influenza Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension.
Advisory Board:
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.
Indications: 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.
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