Glaxo, Theravance Confirms FDA Panel Has Recommended Approval for UMEC/VI 62.5/25mcg Dose for COPD
September 10, 2013 at 15:55 PM EDT
GlaxoSmithKline plc (NYSE: GSK ) and Theravance, Inc. (NASDAQ: THRX ) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for