FDA approved Vidaza for IV route

[JSRN]

GOOD NEWS FOR MY MOM

Pharmion Corporation Announces FDA Approval Of Vidaza NDA Supplement For IV Administration
30 Jan 2007

Pharmion Corporation (Nasdaq: PHRM) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) supplement to add intravenous (IV) use as a new route of administration to the instructions in the approved prescribing information for its DNA demethylating agent Vidaza(R) (azacitidine for injection). With this approval, Vidaza may now 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.

“We are extremely pleased to receive an approval to administer Vidaza via an IV infusion, as this now provides two convenient delivery routes for physicians to meet their MDS treatment goals,” said Patrick J. Mahaffy, Pharmion’s president and CEO. “We believe that offering this kind of flexibility for treatment administration within the label will be very important to physicians and their patients.”

The FDA approval of IV administration of Vidaza was based on existing clinical data from the original NDA, an uncontrolled Phase II study and a bioavailability study, as well as additional data from an in-use stability and compatibility study and a pharmacokinetic modeling study recently completed by Pharmion.
Remainder of article:
http://www.medicalnewstoday.com/medicalnews.php?newsid=61849&nfid=rssfeeds

[Terri]

Thank you for posting this we have been waiting.

[sdrake]

What are the advantages of an IV?

Thanks,
Shari

[Author]

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