Ikaria Holdings Inc's subsidiary INO Therapeutics LLC announced today that it has received approval from Australia's Therapeutic Goods Administration (TGA) for INOmax (nitric oxide) for inhalation. INOmax stated that it had received Orphan Drug status, a process by which medical products for rare illnesses are approved, which it has already received in the U.S. Europe, Canada, Singapore and several Latin American countries.
INOmax is indicated for the treatment of near and full-term newborns suffering from hypoxic respiratory failure (HRF), a life-threatening condition that prevents babies' lungs from delivering sufficient oxygen to their bodies.
"As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe," said Ikaria Chairman and CEO David Shaw. "Through our partner, BOC Medical, with its 60 years of experience in Australia, we look forward to bringing this important therapy to neonatal critical care across the Australian continent."
INOmax is expected to be marketed and distributed in Australia starting in January 2008.
[Source: PRNewsWire]
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