Intravenous Carbamazepine Under FDA Review
Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the re-submission of the New Drug Application (NDA) for intravenous carbamazepine, for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible.
The Company's NDA resubmission was in response to the Complete Response Letter issued in 2014. The FDA has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) of intravenous carbamazepine. The proposed U.S. trade name, Carnexiv, is also under consideration with the FDA. An action letter is anticipated before the end of 2016.
Carbamazepine, an anti-epileptic drug (AED), is currently not available as an intravenous formulation for patients unable to tolerate medications by mouth.
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