Search Orphan Drug Designations and Approvals
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| Generic Name: | nitric oxide | |||||||||||||
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| Trade Name: | ||||||||||||||
| Date Designated: | 06/18/2012 | |||||||||||||
| Orphan Designation: | Treatment of persistent pulmonary hypertension in newborns | |||||||||||||
| Orphan Designation Status: | Designated/Approved | |||||||||||||
| Sponsor: |
VERO BIOTECH 387 Technology Circle, Suite 125 Atlanta, Georgia 30313 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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| 1 | Generic Name: | nitric oxide |
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| 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 | |
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