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Glaxosmithkline Plc and Theravance Inc Announce FDA Acceptance Of New Drug Application Submission In US For ANORO ELLIPTA For COPD

Monday, 18 Feb 2013 08:30pm EST 

Glaxosmithkline Plc and Theravance, Inc. 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 U.S. Food and Drug Administration (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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