Proper Name
Influenza Vaccine
Indication
For active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Description
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.
Package Insert
Advanced Facts