Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) (UMEC/VI) for COPD

New Drug Approvals

umeclidinium bromide

vilanterol

Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) (UMEC/VI) for COPD

SOUTH SAN FRANCISCO, CA — 08/01/13 –Theravance, Inc.  today announced that on September 10, 2013, the U.S. Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee will discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO™ ELLIPTA™), sponsored by Glaxo Group (d/b/a GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The advanced display of the Federal Register notice on the advisory committee can be found at:http://www.ofr.gov/OFRUpload/OFRData/2013-18633_PI.pdf

UMEC/VI is a combination of two investigational bronchodilator molecules — GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA™ inhaler. The Prescription Drug User Fee Act (PDUFA)…

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