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Vidaza Approval History

  • FDA approved: Yes (First approved May 19th, 2004)
  • Brand name: Vidaza
  • Generic name: azacitidine
  • Dosage form: for Injectable Suspension
  • Company: Pharmion Corporation
  • Treatment for: Myelodysplastic Diseases

Vidaza (azacitidine) is an antineoplastic agent for the treatment of patients with myelodysplastic syndromes.

Development History and FDA Approval Process for Vidaza

Aug 21, 2008Approval Vidaza Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
Jan 30, 2007Approval Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration
May 19, 2004Approval FDA Approves Vidaza for Myelodysplastic Syndromes (MDS)
Feb 23, 2004FDA Accepts Pharmion's New Drug Application for Filing and Grants Priority Review for Vidaza for the Treatment of Myelodysplastic Syndromes (MDS)

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