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Afluria Quadrivalent
Proper Name
Influenza Vaccine (Quadrivalent)
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.

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

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

Advanced Facts