According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013. The two companies submitted the NDA in December 2012.
GSK and Theravance also submitted an MAA for Anoro earlier this year, and that application has been accepted by the EMA.
Read the GSK/Theravance press release.
