Mallinckrodt has been awarded Australian approval for INOmax (nitric oxide) gas, for perioperative pulmonary hypertension in adults, in conjunction with cardiovascular surgery.
The decision expands the label for INOmax, which has previously been approved for the same indication in children, as well as for the treatment of hypoxic respiratory failure (HRF) in certain newborns.
Chief scientific officer Steven Romano said: "This expanded approval of INOmax in Australia for cardiovascular surgery in adults is an important milestone for Mallinckrodt, confirming the benefit this therapeutic option can bring to perioperative pulmonary hypertension patients.”
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