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March 10, 2014
10:13 EDTLGNDLundbeck announces FDA acceptance of NDA submission for Carbamazepine IV
Captisol licensee Lundbeck LLC today announced that the U.S. Food and Drug Administration has accepted for review a New Drug Application for its investigational therapy intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug carbamazepine. An action letter is anticipated before the end of 2014. Carbella Injection is the proposed U.S. trade name. With acceptance of the NDA filing, Ligand earns a $200,000 milestone payment.
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