TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the U.S. Food and Drug Administration (FDA) indicated that the Company has the necessary pivotal data to file a New Drug Application (NDA) for Ceplene® (histamine dihydrochloride) in conjunction with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia (AML). At a pre-NDA meeting held last week, the FDA provided guidance that it would accept the clinical data along with other analyses, some of which had been submitted as part of the Ceplene® Marketing Authorization Application (MAA), which was approved in Europe in October 2008.
