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NEJM Perspective: The FDA's review of the risks and benefits of indacaterol

Reference: N Engl J Med 2011; 365:2247-2249

Source: N Engl J Med

Date published: 15/12/2011 17:06

Summary
by: Yuet Wan

In July 2011, the FDA approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist (LABA), at a dose of 75 mcg once daily as a bronchodilator for patients with chronic obstructive pulmonary disease. The European Medicines Agency, however, approved doses of 150mcg and 300 mcg in 2009. This perspective in the New England Journal of Medicine examines why the FDA selected a 75mcg dose.

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