Dacogen
Generic name: decitabine
Treatment for: Myelodysplastic Diseases
SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen
DUBLIN, Calif., April 22, 2004 -- SuperGen Inc. announced today that the Food and Drug Administration has granted its request for a rolling NDA submission for Dacogen (decitabine) for injection. The planned NDA will focus on patients with Myelodysplastic Syndromes (MDS). SuperGen anticipates it will begin submitting data in this quarter, and will complete its submissions by the end of the third quarter of 2004.
The rolling submission is an FDA provision available to drug candidates that have received Fast Track designation, and allows for completed sections of an NDA to be submitted on an ongoing basis. Fast Track status for Dacogen was granted by the FDA on May 9, 2003.
"This is an important milestone for SuperGen," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "The rolling submission will help us to realize our commitment to bring Dacogen through the review process in a timely, thorough and efficient manner."
MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukemia. According to the Aplastic Anemia and MDS International Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS are diagnosed annually in the United States. The number of new cases diagnosed each year is increasing. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease.
Based in Dublin, Calif., SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders.
Posted: April 2004
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- MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS - November 15, 2005
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- 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
Dacogen (decitabine) FDA Approval History
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