Meda AB: FDA Accepts NDA filing for Retigabine

STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for Retigabine. In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA (Marketing Authorization Application) was successfully validated thus enabling the MAA review to commence. Retigabine comprises a new way of affecting potassium channels in the central nervous system. It has been documented to treat epilepsy and has a different mechanism of action compared to current antiepileptic therapies.