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Flulaval Quadrivalent
Proper Name
Influenza Vaccine
For active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

FLULAVAL QUADRIVALENT, Influenza Vaccine, for intramuscular injection, is a quadrivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs.

Key Regulatory Milestones

10/05/2006 - FluLaval was licensed in the U.S.

06/01/2011 - Clarification letter was issued to GSK containing PREA-related PMRs.

03/18/2014 - Type C meeting held (FLU Q-QIV-022)

11/26/2016 - PDUFA Goal Date

07/02/2020 - FDA approval date

Advisory Committee

This submission was not discussed at a VRBPAC meeting because review of this submission did not identify concerns or issues which would have benefited from an advisory committee discussion.

Advanced Facts