ARTICLE | Clinical News

Indacaterol/glycopyrronium bromide regulatory update

November 9, 2015 8:00 AM UTC

FDA approved an NDA from Novartis for Utibron Neohaler indacaterol/glycopyrronium bromide for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Novartis said the product will be available in 1Q16. Utibron Neohaler is a fixed-dose combination of glycopyrronium bromide ( NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). ...