ARTICLE | Clinical News

Ultibro Breezhaler indacaterol/glycopyrronium bromide regulatory update

January 26, 2015 8:00 AM UTC

Vectura said Novartis submitted an NDA last quarter to FDA for QVA149 for long-term maintenance of chronic obstructive pulmonary disease (COPD). Vectura is eligible to receive a milestone payment upon FDA acceptance of the application. The product 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). ...