GlaxoSmithKline plc (GSK,GSK.L) and Theravance Inc. (THRX) announced the FDA acceptance of the New Drug Application or NDA for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" or FF/VI for patients with chronic obstructive pulmonary disease or COPD, thereby indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act or PDUFA goal date has also been confirmed as May 12, 2013.
On July 13, 2012, GSK and Theravance reported the submission by GSK of regulatory applications in the U.S. and European Union for FF/VI for patients with COPD and a regulatory application for asthma in the European Union. The Marketing Authorisation Application or MAA for FF/VI for COPD and asthma has been validated by the European Medicines Agency or EMA.
In addition, GSK submitted a Japanese New Drug Application for FF/VI for patients with COPD and asthma on September 25, 2012.
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