Posted by Michael Wonder on 28 May 2017
Sunovion announces FDA filing acceptance of new drug application for SUN-101/eFlow for the treatment of patients with chronic obstructive pulmonary disease
13 October 2016 - SUN-101/eFlow (glycopyrrolate) NDA is currently under review; if approved, it would represent the first available nebulised long-acting muscarinic antagonist for patients with chronic obstructive pulmonary disease.
Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist, delivered via PARI’s innovative investigational eFlow closed system nebuliser, for the long- term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.
The expected action date by the FDA under the Prescription Drug User Fee Act is 29 May 2017.
