Search Orphan Drug Designations and Approvals
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| Generic Name: | carglumic acid | ||||||||||||||||
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| Trade Name: | Carbaglu | ||||||||||||||||
| Date Designated: | 06/17/2014 | ||||||||||||||||
| Orphan Designation: | Treatment of organic acidemias | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Recordati Rare Diseases 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: | 01/22/2021 | |
| Approved Labeled Indication: | in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) | |
| Exclusivity End Date: | 01/22/2028 | |
| Exclusivity Protected Indication* : | in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) | |
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