Afluria Quadrivalent

Proper Name: Influenza Vaccine (Quadrivalent)

AFLURIA QUADRIVALENT, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension

Indications: For active immunization of person ages 18 years and older against influenza disease caused by influenza virus subtype A and type B present in the vaccine.

Key Regulatory Milestones:

09/28/2007 – Afluria TIV, developed by CSL Biotherapies (renamed as bioCSL in 2014), was granted accelerated approval(STN 125254/0).

11/10/2009 – accelerated approval was extended to include children 6 months to 18 years of age in response to the 2009 H1N1 influenza pandemic.

12/02/2011 – traditional approval was granted for individuals 18 years of age and older (STN 125254/259).

07/2015 – bioCSL and the influenza vaccines business of Novartis merged to form Seqirus.

08/26/2016 – Afluria QIV was approved in adults 18 years of age and older (STN 125254/565).

10/31/2017 – Seqirus submitted a supplement to Biologics License Application.

12/01/2018 – PDUFA Goal Date

07/02/2020 – FDA approval date

Package Insert