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surf1944

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surf1944

Re: surf1944 post# 42

Tuesday, 02/19/2013 9:10:11 AM

Tuesday, February 19, 2013 9:10:11 AM

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7:02AM Theravance and GlaxoSmithKline (GSK) announce FDA acceptance of New Drug Application submission in the US for ANORO ELLIPTA for COPD (THRX) 22.13 : Co and GlaxoSmithKline (GSK) announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 18 December 2013.

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