DACOGEN NDA ACCEPTED FOR FILING BY FDA

MGI Pharma and SuperGen have announced that the new drug application (NDA) for Dacogen for injection was accepted for filing by the FDA.

The NDA for Dacogen (decitabine) injection was submitted to the FDA on Nov. 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Dacogen injection.