FDA approves GSK’s FLUARIX QUADRIVALENT

GSK asserted that it has received approval from the US FDA center for biologics Evaluation and Research thereby hinting at the usage of FLUARIX QUADRIVALENT in persons 6 months and older. Prior to this , the vaccine was approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

Patrick Desbiens, Senior Vice President, US Vaccines claimed “The expanded indication for FLUARIX QUADRIVALENT in the US builds upon GSK’s commitment to being a reliable supplier and partner to healthcare providers and their patients. We can now offer two flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness.”

The supplemental Biologics License application was based on a Phase III pivotal study of the efficiency of FLUARIX QUADRIVALENT.