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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: intravenous carbamazepine
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
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.

Marketing approved:

1 Generic Name: intravenous carbamazepine
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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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