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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:
Date Designated: 06/18/2012
Orphan Designation: Treatment of persistent pulmonary hypertension in newborns
Orphan Designation Status: Designated/Approved
387 Technology Circle, Suite 125
Atlanta, Georgia 30313
United States

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

Marketing approved:

1 Generic Name: nitric oxide
Trade Name:
Marketing Approval Date: 12/20/2019
Approved Labeled Indication: GENOSYL® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Exclusivity End Date: TBD  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.