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surf1944

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surf1944

Re: surf1944 post# 32

Wednesday, 09/26/2012 8:23:00 AM

Wednesday, September 26, 2012 8:23:00 AM

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4:04AM Theravance and GlaxoSmithKline (GSK) receive FDA acceptance of FF/VI New Drug Application submission in the US for COPD (THRX) 25.76 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announce that the New Drug Application for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" for patients with chronic obstructive pulmonary disease, has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date has also been confirmed as 12th May 2013. GSK also submitted a Japanese New Drug Application for FF/VI for patients with COPD and asthma on 25th September 2012.

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