The FDA has approved Symbicort 160/4.5 micrograms (budesonide/formoterol fumarate dehydrate, from AstraZeneca) for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This approval is based on results from two clinical trials, which found Symbicort significantly improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies.

Symbicort is approved for the long-term maintenance treatment of asthma in patients ≥12yrs old not adequately controlled on other asthma-controller medications (eg, low-medium dose inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with two maintenance therapies.

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