Novartis has launched its once-daily Arcapta Neohaler indacaterol inhalation powder 75 mcg for the maintenance treatment of COPD in the US. The FDA approved the indacaterol product at the 75 mcg level in July 2011 but rejected higher doses. The agency explained its reasoning in an article in the New England Journal of Medicine in December 2011.
In Europe, where indacaterol is approved in doses of 150 mcg and 300 mcg, Novartis markets its indacaterol inhaler as the Onbrez Breezhaler. According to the company, the product is now available in over 30 countries, and it plans to introduce the inhaler in additional countries by the end of the year.
Novartis President Andre Wyss commented, “Arcapta Neohaler represents an important new treatment option for the 14 million Americans living with COPD. The launch of Arcapta Neohaler is a significant milestone as we continue to establish a strong respiratory presence in the US market.”
Read the Novartis press release.