Fluzone, Fluzone High-Dose and Fluzone Intradermal
Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs.
Advisory Board:
This submission was not discussed at a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting because review of this submission did not identify concerns which would have benefitted from an advisory committee discussion.
Indications: Fluzone is indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Fluzone High-Dose is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Key Regulatory Milestones:
04/30/2015 – PDUFA Goal Date
07/02/2019 – FDA approval date