GSK receives FDA approval for expanded indication for FluLaval Quadrivalent

Indication now includes use in children 6 months and older.

"The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the US every flu season," said Patrick Desbiens, Senior Vice President, US Vaccines. "Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness. This expanded indication builds upon GSK's commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the US market."

Before the approval of an expanded age indication for FluLaval Quadrivalent, providers who preferred prefilled syringes had to order and stock two separate influenza vaccines to be able to immunize all patients. With this approval, providers are now able to use the same dose of FluLaval Quadrivalent (15 ug of hemagglutinin per virus strain in 0.5 mL) to vaccinate all recommended persons aged 6 months and older.

The supplemental Biologics License Application was based on one Phase III pivotal study and three supportive clinical studies conducted in children 6 months through 35 months of age.