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Home » Health » Arcapta Neohaler gains FDA approval for Treatment of COPD

Arcapta Neohaler gains FDA approval for Treatment of COPD

By Jason Chang on July 5, 2011

Lungs Diagram Credit: National Cancer Institute - PDDigital News Report – The US Food and Drug Administration (FDA) approved Aracapta Neohaler (indacaterol inhalation powder) for treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis, and/or emphysema.

The once-daily treatment is for long-term use that helps muscles surrounding the airways in the lungs to relax, which can help prevent wheezing and feeling of breathlessness. Novartis Pharmaceuticals Corp. are the makers of Arcapta Neohaler.

Arcapta Neohaler is not approved for treatment of asthma or sudden, severe onset of COPD.

The FDA said that the six clinical trials of 5,474 patients over the age of 40 with COPD had shown to be beneficial for treatment. However, there will be a box warning on this medication saying that long-acting beta2 adrenergic agonists (LABA) could have an increased risk from asthma-associated death.

Arcapta Neohaler carries a boxed warning saying long-acting beta2 adrenergic agonists (LABA) increase the risk of asthma-related death. The FDA warns that no LABA medications, including Arcapta Neohaler, should be used with asthma patients unless it is taken along with a long-term asthma control medication.

Common side effects of Arcapta Neohaler include runny nose, cough, headache, sore throat, and nausea.

By: Jason Chang

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