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news.Ikaria, through its subsidiary Ino Therapeutics, has announced that the Japan's Ministry of Health, Labor, and Welfare's Council on Drugs and Food Sanitation has recommended approval of the company's INOflo for inhalation.
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INOflo (brandname INOmax in the US) will be indicated for the treatment of newborns who suffer from hypoxic respiratory failure, a potentially life-threatening condition that keeps babies’ lungs from delivering enough oxygen to their bodies. INOflo is expected to be officially approved by Japan’s Ministry of Health, Labor and Welfare in July 2008.
INOflo is said to be the first pharmaceutical gas approved in Japan, a designation it also has received in the US, Europe, Canada, Australia, Singapore and several countries in Latin America.
Daniel Tasse, president and CEO of Ikaria, said: “As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe. We look forward to bringing this important therapy in neonatal critical care to Japan.”