Showing posts with label Approves. Show all posts
Showing posts with label Approves. Show all posts

Friday, 22 August 2014

FDA Approves Arnuity Ellipta

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma
20 August 2014 -- GlaxoSmithKline plc today announced that the Food and Drug Administration 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.

GlaxoSmithKline’s inhaled corticosteroid Arnuity Ellipta (fluticasone furoate) has been granted approval by the US Food and Drug Administration.
The once-daily inhaler can now be prescribed for maintenance treatment of asthma, as prophylactic therapy in patients aged 12 years and older, but it is not meant to be used for relief of acute bronchospasm.
The decision, which comes on the back of clinical trial data involving more than 3,600 patients, sees Arnuity Ellipta become the first asthma treatment from GSK’s new portfolio to have gain entry to the all important US market.
Around 26 million people in the US currently have asthma, and, despite medical advances, more than half of patients continue to experience poor control and significant symptoms, notes the UK drug giant, highlighting the room for new and effective therapies to help control the disease.
GSK's dry powder inhaler Ellipta is being used to deliver a variety of therapies for asthma and chronic obstructive pulmonary disease around the globe. 

Thursday, 19 December 2013

FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease

December 18, 2013 -- The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States
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