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surf1944

02/19/13 9:10 AM

#43 RE: surf1944 #42

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.