Flublok

Proper Name: Influenza Vaccine (Trivalent)

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

Advisory Board:

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

Indications: For active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine.

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

Package Insert