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GlaxoSmithKline (GSK): FDA Oks Fluarix Quadrivalent Vaccine

 December 17, 2012 01:05 PM

(By Balachander) GlaxoSmithKline Plc (NYSE: GSK) said the U.S. health regulators have cleared its four-strain seasonal influenza vaccine for use in the United States.

The U.S. Food and Drug Administration (FDA) has approved Fluarix Quadrivalent  (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.

Fluarix Quadrivalent is the first intramuscular vaccine to cover against four influenza strains, the U.K. healthcare giant said and added that the vaccine helps protect against the two A strains and adds coverage against a second B strain.  

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The company said Fluarix Quadrivalent will help protect individuals against both B strains and from a public-health standpoint, can help decrease the burden of disease.

GlaxoSmithKline said it will make the vaccine available in time for the 2013-14 flu season and and also plans to fulfill orders for its trivalent vaccines.

Fluarix Quadrivalent is not currently approved or licensed in any country outside of the U.S.

U.S.-listed shares of GSK shed 0.20 percent to trade at $44.03 on Monday.

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