GSK, Theravance pulmonary product accepted for review in U.S., EU

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) said FDA and EMA accepted regulatory submissions for pulmonary product fluticasone furoate/vilanterol. In the U.S., the partners are seeking approval under the name Breo for chronic obstructive pulmonary disease (COPD); the NDA has a May 12, 2013, PDUFA date. In the EU, the partners are seeking approval under the name Relvar to treat asthma and COPD. ...