Anglo-Swedish drug major AstraZeneca's Symbicort (budesonide/formoterol fumarate dihydrate) 160mcg/4.5mcg has been approved in the USA for the twice-daily maintenance treatment of airflow obstruction chronic obstructive pulmonary disease patients.
The approval was based on Phase III trials, which evaluated over 3,600 COPD patients and had significantly greater mean improvements from baseline in pre-dose forced expiratory volume in one second averaged over the treatment period compared with formoterol 4.5mcg and placebo.
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