FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.

  title={FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.},
  author={Edvardas Kaminskas and Ann Farrell and Yong-cheng Wang and Rajeshwari Sridhara and Richard Pazdur},
  journal={The oncologist},
  volume={10 3},
On May 19, 2004, azacitidine (5-azacytidine; Vidaza(trade mark); Pharmion Corporation, Boulder, CO, http://www.pharmion.com) for injectable suspension received regular approval by the U.S. Food and Drug Administration (FDA) for the treatment of all subtypes of myelodysplastic syndrome (MDS). This report summarizes the basis for this approval. Effectiveness was demonstrated in one randomized, controlled trial comparing azacitidine administered s.c. with best supportive care (observation group… CONTINUE READING


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