FDA accepts Pharmion's NDA supplement for IV administration of Vidaza

By Lisa Kerner

Charlotte, N.C., June 13 - The Food and Drug Administration has accepted Pharmion Corp.'s New Drug Application supplement to add IV administration to instructions in the prescribing information for its demethylating agent Vidaza (azacitidine for injectable suspension). In addition, the FDA has established a six-month review goal for the filing.

"We are pleased that the FDA has accepted our application for filing and we look forward to working with the FDA as we seek an approval for physicians to administer Vidaza via an IV infusion of less than one hour," president and chief executive officer Patrick J. Mahaffy said in a company news release.

Even with NDA supplement approval, the dosing for Vidaza would remain the same at 75 mg/m2 daily, for seven days, every four weeks.

In 2004, Vidaza became the first drug approved by the FDA for the treatment of patients with myelodysplastic syndromes, Pharmion said.

Located in Boulder, Colo., Pharmion acquires, develops and commercializes products for the treatment of hematology and oncology patients.

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