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.
Package Insert
Advanced Facts