Search Orphan Drug Designations and Approvals

Marketing approved:
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
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.

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.