DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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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) goal date is December 18, 2013. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance’s key programs include: RELVAR™ ELLIPTA™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance’s web site atwww.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand names ANORO™ and RELVAR™ has not yet been approved by any regulatory authority.
New Drug Approvals 
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