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FDA accepts NDA submission for carbamazepine IV

Ligand Pharmaceuticals Inc.'s (Nasdaq: LGND) Captisol licensee Lundbeck LLC announced that the U.S. Food and Drug Administration has accepted for review a new drug application (NDA) 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 (carbamazepine) Injection is the proposed U.S. trade name.

With acceptance of the NDA filing, San Diego-based Ligand earns a $200,000 milestone payment.

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Ligand Pharmaceuticals

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11119 N. Torrey Pines Rd. Ste., 200
La Jolla, CA 92037

Ligand Pharmaceuticals Executive(s):

John Higgins

  • Chief Executive Officer, President

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NAICS - 541711 - Research and Development in Biotechnology