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Proper Name
Influenza Vaccine (Trivalent)
For active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine.

Flublok [Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular injection

Key Regulatory Milestones

01/16/2013 - Flublok was licensed in the United States for persons 18-49 years of age

11/19/2009 - Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting

10/31/2013 - PSC submitted STN 125285/78 

12/13/2013 - CBER issued a Refuse to File (RTF) letter

01/22/2014 - PSC requested a meeting was scheduled

02/18/2014 - PSC provided a revised supplement (Amendment 8) on and requested that it be filed over protest (FOP).

03/06/2014 - CBER issued a FOP acknowledgment letter to PSC on stating that the supplement had been filed 

10/29/2014 -  new PDUFA goal date

07/07/2017 - FDA approval date

Advisory Committee

A VRBPAC meeting was held on November 19, 2009, for the original Flublok licensing application (STN 125285/0) and there were no issues associated with this supplement that required a new Advisory Committee meeting

Advanced Facts