GlaxoSmithKline says that it submitted a Japanese New Drug Application (JNDA) for its fluticasone furoate (FF)/vilanterol(VI) dry powder inhaler for the treatment of COPD and asthma on September 25, 2012. The FF/VI combination will be delivered by a DPI known as the Ellipta.
GSK and Theravance also announced the acceptance of the FF/VI NDA in the US and said that May 12, 2013 has been set as the PDUFA goal date. The product, previously known as “Relovair” now has the proposed names “Relvar” for Europe and Japan and Breo for the US.
Read the GSK/Theravance press release.
