FDA Accepts Lundbeck Submission of New Drug Application for Intravenous Carbamazepine
March 10, 2014
Lundbeck LLC today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for its investigational therapy intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2014. Carbella™ is the proposed U.S. trade name for intravenous carbamazepine.
Oral carbamazepine is an important treatment option for people with epilepsy.1 However, intravenous carbamazepine formulations are currently not available for patients unable to take the medication by mouth. Intravenous carbamazepine received orphan drug designation from the U.S. FDA in 2013 and is proposed 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.
“Lundbeck has a long-term commitment to helping people with epilepsy, and today is an important milestone toward helping those who may need other options for receiving carbamazepine,” said Torsten Meldgaard Madsen, chief medical officer and vice president of Lundbeck’s US drug development. “We are proud of our portfolio of therapies for people living with epilepsy, and we hope to be able to provide intravenous carbamazepine as another important treatment option.”
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