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FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
Date:2/27/2009

CORT as a treatment option to manage their symptoms and help control the disease over time."

About COPD

In patients with severe to very severe COPD, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the addition of inhaled corticosteroids (ICS) to long-acting beta2-agonists (LABA), in addition to other treatment options.(6) Common symptoms of COPD include shortness of breath, chronic cough, wheezing and excess mucus.(4) COPD is a progressive disease, which means people with COPD can expect lung function to worsen over time.(6) When symptoms are severe, it can be difficult for a person to perform simple, daily tasks.(4) As the disease progresses, people with COPD may eventually require long-term oxygen therapy.(6)

About SYMBICORT

SYMBICORT 160/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.(2) For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg two inhalations twice daily. SYMBICORT is also indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2) Administered twice daily,(2) SYMBICORT is a combination of two proven respiratory medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).(2) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of COPD or asthma.(2)

Important Safety Information

Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. In two placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not occur with greater incidence in the SYMBICORT 160/4.5 group compared with placebo, while the incidence of lung infections other than pneum
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SOURCE AstraZeneca
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