Pharmion seeks FDA OK to administer Vidaza intravenously

By Elaine Rigoli

Tampa, Fla., March 30 - Pharmion Corp. said it submitted a New Drug Application supplement to add intravenous administration to instructions in the prescribing information for its demethylating agent Vidaza. The drug is currently indicated for injection.

The submission to the Food and Drug Administration is based on existing clinical data and new studies recently completed by Pharmion, according to a news release.

Under the proposed prescribing information, the dosing for Vidaza would remain the same at 75 mg/m2 daily for seven days, every four weeks.

Pharmion said it anticipates an FDA response within the standard review time for a New Drug Application supplement of six to 10 months from the date of the submission.

Vidaza, azacitidine for injectable suspension, is used for the treatment of all five subtypes of myelodysplastic syndrome, a bone marrow disorder characterized by the production of abnormally functioning, immature blood cells.

Pharmion is a Boulder, Colo.-based pharmaceutical company that acquires, develops and commercializes products for the treatment of hematology and oncology patients.

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