AFLURIA

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

AFLURIA, 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.

Advisory Board:

A Vaccines and Related Biological Products Advisory Committee meeting was not convened because the review team did not identify any safety or immunogenicity issues necessitating an advisory committee discussion.

Indications: For active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Key Regulatory Milestones:

07/27/2011 – CDRH cleared the 510(k) Stratis device application based on the determination that it was substantially equivalent to the predicate device: PharmaJet 0.5 ml Needle-Free Injection System (K081632).

10/2011 – FDA issued a communication stating that influenza vaccines should be administered by needle and syringe only.

08/22/2014 – PDUFA Goal Date

08/27/2019 – FDA approval date

Package Insert