The sNDA was submitted to the FDA on 6 May 2011 by Eisai.
The submission of the application was supported by the results of Phase III trial compared Dacogen versus treatment choice (TC) of either supportive care or low-dose cytarabine in older patients with newly diagnosed or secondary AML.
The study, which was an open-label, multi-center study involved around 485 patients.
SuperGen developed DACOGEN and receives royalties on global sales.