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FDA Grants Orphan Drug Designation to Ikaria® For Use of Inhaled Nitric Oxide in Pulmonary Arterial Hypertension
Date:1/23/2012

r, speaks to the solid progress of our late-stage pipeline," stated Daniel Tasse, Chairman and CEO of Ikaria.  "We're delighted to have PAH and bronchopulmonary dysplasia as additional indications under investigation for iNO, and also are planning its investigation with the INOpulse DS in chronic obstructive pulmonary disease."

Orphan drug designation is reserved for rare diseases or disorders that affect fewer than 200,000 people in the United States. PAH affects fewer than 200,000 Americans. This designation offers the sponsor tax credits on certain development costs, a waiver of the new drug application (NDA) application user fee, and an exclusivity period of seven years following marketing approval.  In addition to the seven-year marketing exclusivity period granted under the orphan drug designation, the INOpulse DS drug-delivery system would be further protected by developing a portfolio of patents, the last of which expires no earlier than 2029.

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 (>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 addi
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SOURCE Ikaria, Inc.
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