DacogenTreatment for Myelodysplastic Disease
SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen
DUBLIN, Calif., June 01, 2004 -- SuperGen, Inc. (NASDAQ:SUPG) today announced that it has submitted the Chemistry, Manufacturing and Controls (CMC) section as the first component of its New Drug Application (NDA) for Dacogen (decitabine) for injection to the United States Food and Drug Administration (FDA). SuperGen was granted "rolling submission" status for its NDA in April of this year. Dacogen is the company's investigational agent for the treatment of myelodysplastic syndromes (MDS), a cancer of the bone marrow that can be fatal. The Company intends to complete the NDA submission within the third quarter of 2004, during which the remaining sections of the NDA will be submitted.
"Completing submission of the NDA for Dacogen is one of our top priorities, and this event marks a major milestone in this process," stated Dr. Audrey Jakubowski, Senior Vice President Regulatory Affairs and Quality Assurance. "I am confident that our application will be completed within the third quarter. We are working very closely with the Oncology Division of the FDA to manage the review of two applications in the same calendar year: Dacogen for MDS and Orathecin(TM) (rubitecan) capsules, for pancreatic cancer which was submitted on January 26th."
A rolling NDA is a process used by the FDA to expedite the review of a drug intended for the treatment of a serious or life threatening condition. This allows the FDA to more efficiently utilize its resources to complete a timely review. SuperGen obtained FDA agreement to submit this rolling NDA based on "Fast Track" status granted in April, 2003.
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: June 2004
- FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS) - March 12, 2010
- Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA - December 15, 2005
- 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 Announces FDA Acceptance of Rolling NDA Request for Dacogen - April 22, 2004