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FDAnews Drug Daily Bulletin
July 27, 2012 | Vol. 9 No. 147
GSK and Theravance Submit NDA on Respiratory Drug Candidate
GlaxoSmithKline (GSK) and Theravance have submitted applications in the U.S. and European Union for a new chronic obstructive pulmonary disease (COPD) and asthma treatment. In the U.S., the companies submitted an NDA for Breo — a once-daily corticosteroid/long-acting beta-agonist combination of GSK’s Veramyst (fluticasone furoate) and vilanterol — to treat COPD in patients with an exacerbation history.
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