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www.fdanews.com/articles/114247-epicept-receives-permission-to-file-ceplene-nda

EpiCept Receives Permission to File Ceplene NDA

February 2, 2009
EpiCept Corporation announced that the U.S. Food and Drug Administration 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).
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