GSK submits NDA for fluticasone furoate DPI

According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg and 200mcg doses of FF delivered by the Ellipta DPI.

The FDA approved GSK and Theravance’s Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD in May 2013.

GSK says that it will submit applications for FF monotherapy in other countries beginning in 2014.

Read the GSK press release.