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22 Aug 2014

GSK Receives FDA Approval for Arnuity Ellipta (Fluticasone Furoate) in the US for the Treatment of Asthma

GlaxoSmithKline (GSK) has announced that FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.

 

The approved doses are Arnuity Ellipta 100 mcg and 200 mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.

 

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."

 

The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3600 patients with asthma.

 

Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.

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