Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent (influenza vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was only approved for active immunisation against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.
The supplemental biologics license application was based on a Phase III pivotal study of the efficacy of Fluarix Quadrivalent in children 6 months through 35 months of age and on two supportive studies.
