Pharmion's NDA supplement for IV administration of its demethylating agent Vidaza (azacitidine) has a Sept. 29 user fee date under a six-month review, the company announced June 13.

If approved, dosing for the myelodysplastic syndromes treatment will remain the same at 75 mg/m2 daily, for seven days, every four weeks and will be administered via infusion of less than one hour. The product is currently dosed as a subcutaneous injection.

Vidaza was approved in May 2004 to treat MDS patients with refractory anemia or refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation and chronic myelomonocytic leukemia (¹ Also see "Pharmion Vidaza To Be Launched By July 1 For Bone Marrow Disorder" - Pink Sheet, 19 May, 2004.).

Vidaza IV Granted Priority Review

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