AGRIFLU, Influenza Virus Vaccine, for intramuscular injection is a trivalent inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate.
11/27/2009 - Agriflu was approved for active immunization against influenza in adults 18 years of age and older
10/30/2010 - PDUFA Goal Date
01/28/2020 - FDA approval date
This sBLA did not meet any of the factors for presentation to an advisory committee as described in FDA Draft Guidance, “Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings.” Therefore, the application was not discussed at a meeting of the Vaccines Related Products Advisory Committee.