Flulaval Quadrivalent
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.
Advisory Board:
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.
Indications: For active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
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