U.S. FDA approves Carnexiv™ (carbamazepine) injection as intravenous replacement therapy for oral carbamazepine formulations
Carbamazepine has been one of the recommended treatment standards for people with epilepsy[i]
Carnexiv is the first FDA-approved intravenous carbamazepine option in the U.S.
Healthcare professionals will now be able to provide continuity of care for certain patients with epilepsy when oral carbamazepine cannot be administered
Valby, Denmark, 7 October 2016 – H. Lundbeck A/S (Lundbeck) today announced that the U.S. Food and Drug Administration (FDA) has approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv has received orphan drug designation from the U.S. FDA for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the U.S. in early 2017.
Carnexiv is a short-term (≤7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have the following seizure types:
• Partial seizures with complex symptomatology
• Generalized tonic-clonic seizures
• Mixed seizure patterns which include the above, or other partial or generalized seizures
Read more: https://globenewswire.com/news-release/2016/10/07/878046/0/en/U-S-FDA-approves-Carnexiv-carbamazepine-injection-as-intravenous-replacement-therapy-for-oral-carbamazepine-formulations.html