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AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Date:3/11/2010

160/4.5 mcg is also indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg two inhalations twice daily. SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of COPD or asthma. SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.

For more information about SYMBICORT, please visit www.MySYMBICORT.com.

Important Safety Information, including boxed WARNING

WARNING: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another l
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SOURCE AstraZeneca
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