|GlaxoSmithKline Receives FDA Approval For Arnuity Ellipta; Hospira Granted Temporary Restraining Order Against FDA|
|By Staff and Wire Reports|
|Wednesday, 20 August 2014 18:29|
GlaxoSmithKline plc (NYSE:GSK) announced that the 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 100mcg and 200mcg. 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 3,600 patients with asthma.
Full US Prescribing Information, including Patient Information Leaflet, will be available soon at: us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Inquiries" section at the end of this document.
Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.
Shares of Hospira (NYSE: HSP) are trading higher after the company was granted a temporary restraining order against the U.S. Food and Drug Administration over the agency's approval of generic versions of the company's top-selling drug, Precedex.
Precedex is a sedative that accounts for nearly 11 percent of Hospira's total revenue.
Shares of Hospira are up 2.23 percent At $55.12.
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