Vidaza has already been approved by the FDA in 2004, as a drug to be administered subcutaneously, for patients with myelodysplastic syndromes. The FDA approval of intravenous (IV) administration of Vidaza was based on existing clinical data from the original new drug application.
Since this approval is for an alternative administration of the existing formulation, Pharmion will begin promoting this IV route of administration immediately.
With IV administration, the dosing for Vidaza remains the same as the previously approved subcutaneous administration at 75mg/m2 daily, for seven days, every four weeks. Vidaza may now be administered intravenously over a period of 10 to 40 minutes in a clinic or hospital setting.