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FDA queries need for higher dose of Novartis LABA COPD drug

This article was originally published in Scrip

Executive Summary

US drug reviewers said Novartis' 150mcg dose of its investigational chronic obstructive pulmonary disease (COPD) drug indacaterol provides no meaningful clinical benefit over the 75mcg dose – a conclusion that could pose a problem down the road for the company's experimental combination COPD product, which contains the higher dose of the agent.



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