Dacogen

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN® (decitabine) for injection in the treatment of acute myeloid leukemia. Acute myeloid leukemia (AML) is a life-threatening cancer of the blood for which there are few treatment options.
Acceptance of the sNDA indicates that the FDA has found the company’s submission to be sufficiently complete to review. The sNDA was submitted to the FDA on May 6, 2011.