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