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Dacogen Approval History

  • FDA approved: Yes (First approved May 2nd, 2006)
  • Brand name: Dacogen
  • Generic name: decitabine
  • Dosage form: for Injection
  • Company: MGI Pharma Inc. and SuperGen Inc.
  • Treatment for: Myelodysplastic Diseases

Dacogen (decitabine) is a hypomethylating agent indicated for treatment of patients with myelodysplastic syndromes (MDS), a cancer of the bone marrow.

Development History and FDA Approval Process for Dacogen

Mar 12, 2010Approval FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Dec 15, 2005Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
Nov 15, 2005MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS
Sep  1, 2005Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS.
Jan  3, 2005Dacogen NDA Accepted for Filing by FDA
Nov  1, 2004SuperGen and MGI Pharma Announce Submission of Dacogen NDA to US FDA
Jun  1, 2004SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen
Apr 22, 2004SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen

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