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Novartis launches Arcapta™ Neohaler™, a novel once-daily bronchodilator for chronic obstructive pulmonary disease
Date:3/19/2012

reatment groups.

Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez® Breezhaler®. It is now approved in more than 80 countries for the treatment of COPD, and is available in more than 30 countries with additional launches planned during 2012.

Important Safety InformationWARNING: ASTHMA-RELATED DEATHLong-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that 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 is considered a class effect of LABA, including indacaterol, the active ingredient in Arcapta Neohaler. The safety and efficacy of Arcapta Neohaler in patients with asthma have not been established. Arcapta Neohaler is not indicated for the treatment of asthma.All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication.

Arcapta Neohaler should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

Arcapta Neohaler should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2-agonists as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

Arcapta Neohaler may produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Arcapta Neohaler should be discontinued immediately and alternative therapy instituted.

Arcapta Neohaler can produce a clinically signific
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SOURCE Novartis Pharmaceuticals Corporation
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