Valeant Pharmaceuticals International announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (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 (EMEA) confirmed on November 17, 2009 that the MAA was successfully validated thus enabling the MAA review to commence. The filings were submitted on October 30, 2009.
Retigabine is a neuronal potassium channel opener currently in late-stage development as an adjunctive treatment for adult patients with partial-onset seizures.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.