FDA Approves Expanded Indication for Fluarix Quadrivalent
GlaxoSmithKline announced that the Food and Drug Administration (FDA) has expanded the indication for Fluarix Quadrivalent (quadrivalent inactivated "split virus" influenza vaccine) to include use in patients aged ≥6 months for active immunization against influenza A subtype viruses and type B viruses.
Fluarix Quadrivalent was initially approved in 2012 for use in patients aged ≥3 years. It contains 15µg hemagglutinin per virus strain in 0.5mL suspension and is intended for intramuscular (IM) injection. The FDA's expanded approval was supported by Phase 3 efficacy data that included children aged 6–35 months as well as 2 supportive studies.
Fluarix Quadrivalent is supplied as prefilled syringes in 10-count packages.
For more information call (888) 825-5249 or visit us.gsk.com.