BioCentury
ARTICLE | Clinical News

Inhaled nitric oxide regulatory update

November 19, 2012 8:00 AM UTC

GeNO said FDA accepted for review an NDA for inhaled NO delivered via the GeNOsyl MVG-2000 Nitric Oxide Delivery System to treat neonates with hypoxic respiratory failure. GeNO said the PDUFA date is in June 2013, but the company did not disclose an exact date. GeNO said FDA determined an NDA would be necessary because the combination product's primary mode of action is the inhaled NO drug component. Inhaled NO delivered via MVG-2000 has Orphan Drug designation in the U.S. to treat persistent pulmonary hypertension (PPH) in newborns. ...