Search Orphan Drug Designations and Approvals
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Generic Name: | intravenous carbamazepine | ||||||||||||||||
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Trade Name: | CARNEXIV | ||||||||||||||||
Date Designated: | 06/27/2013 | ||||||||||||||||
Orphan Designation: | Treatment of epilepsy patients who cannot take anything by mouth (NPO) | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Lundbeck LLC 3530 Toringdon Way, Suite 200 Charlotte, North Carolina 28277 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: | intravenous carbamazepine |
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Trade Name: | CARNEXIV | |
Marketing Approval Date: | 10/07/2016 | |
Approved Labeled Indication: | Replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types: (1) Partial seizures with complex symptomology; (2)Generalized tonic-clonic seizures; and (3) Mixed seizure patterns which include the above or other partial or generalized seizures | |
Exclusivity End Date: | 10/07/2023 | |
Exclusivity Protected Indication* : | Replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types: (1) Partial seizures with complex symptomology; (2)Generalized tonic-clonic seizures; and (3) Mixed seizure patterns which include the above or other partial or generalized seizures | |
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