APPROVABLE LETTER RECEIVED FOR DACOGEN INJECTION

MGI Pharma and SuperGen announced that they have received an approvable letter from the FDA for Dacogen injection for the treatment of myelodysplastic syndromes (MDS). The letter provides that Dacogen injection is approvable pending the FDA's review of a requested analysis of the transfusion requirements of patients enrolled in the completed Phase III trial, submission of certain other information, and completion of labeling discussions.