FLUCELVAX

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

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.

Indications: 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.

Key Regulatory Milestones:

07/22/2016 – PDUFA goal date

08/31/2016 – FDA approval date

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