Monday, April 25, 2016
The FDA has accepted for review the resubmission of Lundbeck’s New Drug Application (NDA) for intravenous Carnexiv, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2016. Lundbeck’s resubmission was in reply to the Complete Response Letter from the FDA issued in 2014 requesting additional data associated with the Chemistry, Manufacturing and Controls (CMC) of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.