GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name Incruse Ellipta in the US, in Canada, and in Europe in April 2014. According to GSK, “Regulatory filings in other countries will take place throughout 2014 and onwards.”
The company submitted an NDA for its Anoro Ellipta UMEC/vilanterol DPI in Japan in April 2013.
Read the GSK press release.
