FDA approves IV formulation of Lundbeck's Carnexiv

8 October 2016

The US Food and Drug Administration has approved Danish CNS specialist Lundbeck’s (LUND: CO) 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 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 US 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:

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