The FDA has approved Novartis’s Arcapta Neohaler with a 75 mcg once-daily dose of indacaterol for the treatment of COPD. Novartis sells an indacaterol inhaler in Europe as the Onbrez Breezhaler. The company plans to launch the Arcapta Neohaler in the US in the first quarter of 2012.
An FDA advisory committee recommended approval of the 75 mcg dose in March 2011 but voted against approval of a 150 mcg dose citing safety concerns. The Onbrez Breezhaler is approved at 150 mcg and 300 mcg doses in more than 50 countries.
Trevor Mundel, Novartis Pharmaceuticals Division Global Head of Development said, “Novartis is focused on bringing innovative, safe and effective COPD medicines to patients and physicians. Indacaterol is the cornerstone of our respiratory portfolio and this US approval represents a significant clinical and regulatory milestone.”
Read the Novartis press release.
