FluLaval

Proper Name: Influenza Virus Vaccine (Trivalent, Types A and B)

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.

Advisory Board:

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.

Indications: Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.

Key Regulatory Milestones:

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

Package Insert