EpiCept Corporation Announces Filing of New Drug Submission for Approval of Ceplene in Canada

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.

MORE ON THIS TOPIC