22 April 2016 - Lundbeck today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application for intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug 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 of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.

For more details, go to: https://lundbeck.com/upload/us/files/pdf/2016_Releases/Carnexiv%20NDA%20Press%20Release%204.22.16%20FINAL.pdf