Search Orphan Drug Designations and Approvals
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| Generic Name: | Nitric oxide | ||||||||||||||||
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| Trade Name: | INOmax | ||||||||||||||||
| Date Designated: | 06/22/1993 | ||||||||||||||||
| Orphan Designation: | Treatment of persistent pulmonary hypertension in the newborn. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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* : | ||
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