MNKPF - Mallinckrodt files for FDA approval of inhaled nitric oxide delivery system

• Mallinckrodt ( NYSE: MNK ) ( OTCPK:MNKPF ) said it filed a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) seeking clearance for an inhaled nitric oxide delivery system for INOmax (nitric oxide) gas for inhalation.
• The company added that INOmax (nitric oxide) gas, for inhalation, is an FDA-approved treatment for improving oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure linked with evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
• If cleared, the next-generation inhaled nitric oxide delivery system would be among the dual channel delivery systems, which combine automation, integration and interaction in one device, the company said in a Sept. 28 press release.

For further details see: