Valeant Pharmaceuticals International (VRX) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application or NDA seeking marketing approval for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
In addition, the European Medicines Agency confirmed on November 17, 2009 that the MAA was successfully validated thus enabling the MAA review to commence.
Valeant said that it has a worldwide License and Collaboration Agreement with GlaxoSmithKline Plc. (GSK, GSK.L), to develop and commercialize retigabine. Valeant will collaborate with GSK on the development and marketing of retigabine in the United States, Australia, New Zealand, Canada and Puerto Rico (Collaboration Territory) and GSK has an exclusive license to develop and commercialize retigabine in countries outside of the Collaboration Territory and certain backup compounds to retigabine worldwide.
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