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AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
Date:4/30/2008

eatment options.(6) 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.(1) As the disease progresses, people with COPD may eventually require supplemental oxygen and may have to rely on mechanical ventilatory assistance.(7)

About SYMBICORT

SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(4) Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).(4) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(4)

Important Safety Information

Long acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients 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 U.S. study compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.

SYMBICORT is not indicated for the relief of acute bronchospasm.

SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adren
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SOURCE AstraZeneca
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