Acute Myeloid Leukemia

Dacogen (decitabine) for Injection receives U.S. orphan drug designation for patients with AML

Published in Drug Week, September 8th, 2006

MGI PHARMA, INC. (MOGN), a biopharmaceutical company focused in oncology and acute care, announced that the U.S. Food and Drug Administration (FDA) has granted Dacogen (decitabine) for Injection orphan designation for the indication of acute myeloid leukemia (AML).

Dacogen was approved by the FDA on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic...

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Source: Drug Week (2006-09-08)

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