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news.The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system.
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GeNOsyl nitric oxide is a vasodilator which is indicated 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.
The system improves oxygenation and reduces the need for extracorporeal membrane oxygenation, according to the company.
GeNO president and founder David Fine said the company is pleased with the FDA’s acceptance of its NDA submission for review as it is a significant achievement in the regulatory approval process.
"The FDA’s acceptance for filing of this NDA follows 510(k) clearance earlier this year of GeNO’s MV-1000 inhaled nitric oxide delivery system, and orphan drug designation of GeNOsyl™ (nitric oxide delivered via the MVG-2000 delivery system)," Fine added.
"We believe that GeNO’s novel nitric oxide delivery systems have the potential to transform the treatment of pulmonary hypertension, and other conditions, by delivering a more pure form of nitric oxide for inhalation that contains lower levels of nitrogen dioxide and are less costly."