GlaxoSmithKline announced that the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research has approved an expanded indication for FluLaval Quadrivalent (influenza vaccine) to include the use in children aged ≥6 months.
Before this approval, FluLaval Quadrivalent was approved for active immunization against influenza A subtype viruses and type B viruses in patients aged ≥3 years. The supplemental Biologics License Application (sBLA) included data from a Phase 3 study and three supportive clinical studies conducted in children 6–35 months of age.
FluLaval Quadrivalent is supplied as 15mcg hemagglutinin per virus strain in 0.5mL. It is available as a single-dose prefilled syringe (0.5mL) and as a multi-dose vial (5mL).
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