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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Nitric oxide
Trade Name: INOmax
Date Designated: 06/22/1993
Orphan Designation: Treatment of persistent pulmonary hypertension in the newborn.
Orphan Designation Status: Designated/Approved
Mallinckrodt Hospital Products
1425 U.S. 206
Bedminster Township, New Jersey 07921
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Nitric oxide
Trade Name: INOmax
Marketing Approval Date: 12/23/1999
Approved Labeled Indication: In conjunction with ventilatory support and other appropriate agents, in the treatment of term and near-term (>34 weeks) 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.
Exclusivity End Date: 12/23/2006 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.