MGI, SuperGen answer FDA questions on Dacogen

New York, Dec. 15 - MGI Pharma, Inc. and SuperGen, Inc. said that the Food and Drug Administration has accepted their resubmission dated Nov. 15 as a complete response to its approvable letter for Dacogen (decitabine) injection.

The resubmission has been designated a class 2 response, and the FDA set May 15, 2006 as the goal for reviewing the response.

Dacogen is a hypomethylating agent intended for the treatment of myelodysplastic syndromes.

SuperGen is a Dublin, Calif., pharmaceutical company focused on therapies for solid tumors, hematological malignancies and blood disorders. It has Orathecin capsules for pancreatic cancer and Nipent for the hairy-cell leukemia.

Atlanta-based MGI Pharma is an oncology and acute care-focused biopharmaceutical company. It markets Aloxi injection and Gliadel Wafer in the United States.

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