FDA approves Novartis’ Utibron Neohaler

EAST HANOVER, N.J. —  Novartis on Friday announced that the Food and Drug Administration had approved its dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder. It is indicated as a long-term maintenance treatment for patients who have airflow obstruction due to chronic obstructive pulmonary disease. 

 

“Patients have told us about the tremendous impact their COPD can have on everyday activities,” Novartis and Novartis Pharmaceuticals president and U.S. head Christi Shaw said. “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.”

 

The FDA also approved the company’s Seebri Neohaler (glycopyrrolate) powder, which part of the Utibron Neohaler, as a standalone COPD monotherapy. Both are expected to be available in the first quarter of 2016.