TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that, at a recent pre-New Drug Submission (pre-NDS) meeting with representatives of Health Canada, it received permission to proceed with a New Drug Submission (NDS) filing for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) in Canada. Based on input received at the pre-NDS meeting, the Company believes that no additional pivotal clinical data beyond that which was submitted as part of the Marketing Authorization Application (MAA) filed for Ceplene in Europe will be required for this NDS filing.
