• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-