GlaxoSmithKline (GSK) Receives FDA Approval for Expanded FluLaval Quadrivalent Indication

November 21, 2016 8:38 AM EST

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GSK (NYSE: GSK) announced it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age 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 FluLavalĀ® 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 FluLavalĀ® Quadrivalent (15ug 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.

For more information about quadrivalent vaccines, visit ChooseMoreChooseFour.com.



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