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.
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