FLULAVAL, Influenza Vaccine, for intramuscular injection, is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs.
10/05/2006 - FluLaval was licensed in the U.S. for the prevention of influenza subtypes A and type B contained in the vaccine under the accelerated approval regulations.
06/01/2011 - clarification letter was issued to GSK containing PREA-related PMR.
03/18/2014 - Type C meeting held for FLU Q-QIV-022.
12/26/2016 - PDUFA Goal Date
02/06/2020 - FDA approval date
The 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.