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FDA Extends Marketing Exclusivity for INOMAX®
Date:1/5/2011

y includes use of Ikaria's proprietary, FDA-cleared drug-delivery system, all related disposable items, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, and 24/7/365 customer service.

About INOMAX®  

INOMAX® is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (greater than 34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen

dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration.  

Please see attached prescribing information.  For additional more information about INOMAX, please visit www.inomax.com.  

About Ikaria, Inc.

Ikaria, Inc. is a biotherapeutics company focused on developing and commercializing innovative therapeutics and interventions designed to address the significant unmet needs of critically ill patients. The company's lead product is INOtherapy®, an all-inclusive offering of drug product, services and technologies. INOMAX® (nitric oxide) for inhalation, the drug included in the INOtherapy offering, is the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term in
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SOURCE Ikaria, Inc.
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