INOmax (nitric oxide) for inhalation has received regulatory approval in Australia and Japan for pulmonary hypertension in conjunction with heart surgery, according to Mallinckrodt.
“The approval of INOmax in Australia and Japan for cardiovascular surgery represents a significant milestone for Mallinckrodt and INOmax,” said Tom Englese, General Manager, Mallinckrodt. “Worldwide, there is a tremendous need for therapies for patients undergoing cardiac surgery. We look forward to helping meet these needs while broadening our reach in global markets.”
INOmax is not approved in the United States for use in patients older than neonates, and is not approved by the FDA for use in the surgical setting.