TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: “This filing is a very important milestone in our strategy for Ceplene, and we are delighted to submit the NDA consistent with the timetable we publicly announced” EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission. Ceplene was approved for this indication by the European Commission in October 2008 and is currently available in the United Kingdom, Germany and Austria. Ceplene is expected to be available throughout most of the European Union within twelve months.
