GeNO LLC announced that its New Drug Application (NDA) for the GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory failure has been accepted for filing by the FDA.

GeNOsyl nitric oxide for inhalation is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is used for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

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