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Proper Name
Influenza Virus Vaccine
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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.

Key Regulatory Milestones

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

Advisory Committee

This sBLA did not meet any of the factors for presentation to an advisory committee as described in FDA Draft Guidance, “Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings.”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.

Advanced Facts