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Fluzone, Fluzone High-Dose and Fluzone Intradermal
Proper Name
Influenza Virus Vaccine (Trivalent, Types A and B)
Indication
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.
Description

Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs.

Key Regulatory Milestones

04/30/2015 - PDUFA Goal Date

07/02/2019 - FDA approval date

Advisory Committee

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.

Advanced Facts