Search Orphan Drug Designations and Approvals
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| Generic Name: | carglumic acid | ||||||||||||||||
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| Trade Name: | Carbaglu | ||||||||||||||||
| Date Designated: | 01/20/1998 | ||||||||||||||||
| Orphan Designation: | Treatment of N-acetylglutamate synthetase deficiency. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Orphan Europe SARL Immeuble Le Wilson 70 avenue du General de Gaulle Puteaux France 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: | carglumic acid |
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| Trade Name: | Carbaglu | |
| Marketing Approval Date: | 03/18/2010 | |
| Approved Labeled Indication: | As an adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS) and as manitenance therapy for chronic hyperammonemia due to NAGS deficiency | |
| Exclusivity End Date: | 03/18/2017 | |
| Exclusivity Protected Indication* : | ||
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