DacogenTreatment for Myelodysplastic Disease
Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
Dacogen injection is a product candidate that belongs to a class of drugs called hypomethylating agents that is currently being evaluated in a broad clinical development program in patients with MDS, acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), and solid tumors. Dacogen injection is not approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. The Dacogen injection New Drug Application (NDA) is under review by the FDA for the MDS indication. A phase 3 EORTC-sponsored trial is currently ongoing in Europe to evaluate Dacogen injection in patients with MDS. MGI PHARMA is conducting a pivotal program to evaluate Dacogen injection in patients with AML. Additional clinical studies are also underway in patients with MDS to evaluate alternative dosing regimens for Dacogen injection.
Posted: December 2005
- FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS) - March 12, 2010
- MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS - November 15, 2005
- Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS. - September 1, 2005
- Dacogen NDA Accepted for Filing by FDA - January 3, 2005
- SuperGen and MGI Pharma Announce Submission of Dacogen NDA to US FDA - November 1, 2004
- SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen - June 1, 2004
- SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen - April 22, 2004
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