GSK files once daily fluticasone furoate for Asthma with FDA
GlaxoSmithKline has announced the submission of a New Drug Application in the US for the once daily inhaled corticosteroid treatment, fluticasone furoate, administered using the Ellipta dry powder inhaler. The NDA has been submitted to the FDA for monotherapy (100mcg and 200mcg doses) as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Regulatory filings for FF monotherapy are planned in other countries from 2014 onwards. FF administered using the Ellipta dry powder inhaler is an investigational medicine and is not currently approved anywhere in the world.
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