nitric oxide

FDA Drug Profile — GENOSYL, INOMAX

Drug Details

Generic Name
nitric oxide
Brand Names
GENOSYL, INOMAX
Application Number
NDA202860
Sponsor
VERO BIOTECH, INC.
NDC Codes
5
Dosage Forms
GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients
NITRIC OXIDE

Indications and Usage

1 INDICATIONS AND USAGE GENOSYL ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. GENOSYL is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents ( 1 ).