Trade Resources Industry Views FDA Has Approved The Supply of GlaxoSmithKline's Four-strain Influenza Vaccine

FDA Has Approved The Supply of GlaxoSmithKline's Four-strain Influenza Vaccine

The US Food and Drug Administration (FDA) has approved the supply of GlaxoSmithKline's four-strain (quadrivalent) influenza vaccine, Fluarix Quadrivalent, to CDC distribution centers and healthcare providers in the US.

Fluarix Quadrivalent became the first FDA approved intramuscular quadrivalent influenza vaccine for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine.

GSK Vaccines North America scientific affairs and public policy vice president Dr Leonard Friedland said trivalent (three-strain) influenza vaccines offer important protection against influenza.

"But since the late 1980s, scientists noted that two B virus lineage strains circulate to varying degrees each year, and it's difficult to predict which one will cause the most illness in a particular influenza season," Friedland added.

"Fluarix Quadrivalent addresses this by protecting against both B strains."

For the current influenza season, GSK will supplement the supply of Fluarix Quadrivalent with its trivalent seasonal influenza vaccines.

Fluarix Quadrivalent also is approved and marketed as INFLUSPLIT Tetra in Germany, while marketed as Fluarix Tetra in the UK.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-supply-of-gsks-quadrivalent-influenza-vaccine-in-us-060813
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FDA Approves Supply of GSK's Quadrivalent Influenza Vaccine in US