Pharmion Corporation (Nasdaq: PHRM) has received USFDA approval for the intravenous (IV) administration of its DNA demethylating agent Vidaza® (azacitidine for injection).
The said approval allows Vidaza® to be administered intravenously over a period of 10 to 40 minutes in a clinic or hospital setting.
With IV administration, the dosing for Vidaza remains the same as the previously approved subcutaneous (SC) administration at 75 mg/m2 daily, for seven days, every four weeks.
Since this approval is for an alternative administration of the existing formulation, Pharmion will begin promoting this IV route of administration immediately.
Vidaza® belongs to a new class of drugs called demethylation agents, which when approved in May 19, 2004, became the first drug approved by the USFDA for the treatment of Myelodysplastic Syndromes (MDS) patients.
Find more details from the press release.
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» USFDA Accepted Pharmion’s IND for Oral Azacitidine (Vidaza®) from PharmaGazette
Submitted in December 2006, Pharmion Corporation (Nasdaq: PHRM) Investigational New Drug (IND) application for the Company's oral formulation of azacitidine is now active following its acceptance by the USFDA. The parenteral formulation of azacitid... [Read More]
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