Proper Name
Influenza Virus Vaccine (Trivalent, Types A and B)
Indication
For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Description
FLUCELVAX (Influenza Vaccine), a vaccine for intramuscular injection, is a subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line.
Key Regulatory Milestones
07/22/2016 - PDUFA goal date
08/31/2016 - FDA approval date
Package Insert
Advanced Facts