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FDA Approves Five-Day Dosing Regimen for Dacogen(R) (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Date:3/11/2010

About MDS

Myelodysplastic syndromes, or MDS, are a potentially life-threatening group of bone marrow diseases that alter the production of functional blood cells. MDS affects mostly people over the age of 60 and is more commonly found in men. People with MDS may experience anemia, neutropenia, and/or thrombocytopenia which can lead to a variety of symptoms including fatigue, shortness of breath, infections, bruising and bleeding. In the United States, between 10,000 and 15,000 new cases of MDS are diagnosed each year.

About Dacogen

Dacogen was first approved by the FDA for treatment of patients with MDS on May 2, 2006. Dacogen (decitabine) for Injection is indicated for 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, chronic myelomonocytic leukemia), and Intermediate-1, In
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