FDA approves new Novartis dual combination bronchodilator Utibron™ Neohaler® for patients with chronic obstructive pulmonary disease

October 30, 2015

East Hanover, NJ - October 30, 2015 -The US Food and Drug Administration (FDA) has approved Novartis' new dual combination bronchodilator Utibron Neohaler inhalation powder for patients with chronic obstructive pulmonary disease (COPD).

Utibron Neohaler (indacaterol/glycopyrrolate) can be used for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Utibron Neohaler demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components. The company said it does not replace the use of a rescue inhaler.

"Patients have told us about the tremendous impact their COPD can have on everyday activities," said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation. "With this approval, the COPD community now has a new medicine that can help so many patients by improving not only their symptoms, but also their health-related quality of life. This means the possibility of doing things that matter to them."

Novartis expects that Utibron Neohaler will be available in the first quarter of 2016.