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Ceplene FDA Approval Status

FDA Approved: No
Brand name: Ceplene
Generic name: histamine dihydrochloride
Company: EpiCept Corporation
Treatment for: Acute Myeloid Leukemia

Ceplene (histamine dihydrochloride) is intended for use in conjunction with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia.

In August 2010, EpiCept Corporation announced the receipt of a Refusal to File Letter from the U.S. Food and Drug Administration (FDA), with the recommendation for company to conduct an additional confirmatory pivotal trial to establish the therapeutic contribution of Ceplene (histamine dihydrochloride) in combination with interleukin-2 (IL-2) using overall survival as a primary endpoint.

Development Timeline for Ceplene

Aug 23, 2010EpiCept Corporation Receives Refusal to File Letter from US FDA on Ceplene New Drug Application
Jun 29, 2010EpiCept Files New Drug Application for Ceplene in AML
Feb  2, 2009EpiCept Receives Permission to File Ceplene NDA

Further information

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