Published in Medical Letter on the CDC and FDA, July 17th, 2005
"This article summarizes data submitted to the U.S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension (Vidaza, Pharmion Corporation) for treatment of patients with myelodysplastic syndrome.
"In one phase 3 controlled trial, 191 study subjects were randomized to treatment with azacitidine or to observation; an additional 120 patients were treated with azacitidine in two-phase 2 single arm studies. The primary efficacy end point was the overall...
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