FDA hands refusal to file letter to EpiCept for lead leukaemia product
This article was originally published in Scrip
Executive Summary
EpiCept has received a rare refusal to file letter from the US FDA for its NDA for its lead product, Ceplene (histamine dihydrochloride), which it was intending to be a maintenance treatment for patients with acute myeloid leukaemia (AML) in their first remission.