Approvable letter:
Approvable Letter Received from the FDA for Dacogen(TM) (Decitabine) Injection for the Treatment of MDS; Conference Call To Be Held At 5:15 PM ET Today, September 1, 2005
1 September 2005, 4:02pm ET
MINNEAPOLIS & DUBLIN, Calif.--(BUSINESS WIRE)--Sept. 1, 2005--MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today announced they have received an approvable letter from the U.S. Food and Drug Administration (FDA) for Dacogen(TM) (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). The letter provides that Dacogen injection is approvable pending the FDA's review of a requested analysis of the transfusion requirements of patients enrolled in the completed phase 3 trial, submission of certain other information, and completion of labeling discussions.
"We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during the fourth quarter," stated Lonnie Moulder, president and CEO of MGI PHARMA. "The MGI PHARMA commercial organization is prepared to launch Dacogen injection upon final FDA approval."
"The approvable letter from the FDA brings Dacogen injection one step closer to patients suffering from MDS," stated Jim Manuso, president and CEO of SuperGen. "I am confident that MGI PHARMA and SuperGen can promptly provide the information that the FDA has requested."
Conference Call & Webcast Information
MGI PHARMA and SuperGen will host a conference call at 5:15 p.m. ET on Thursday, September 1, 2005, to discuss the approvable letter and related matters. Lonnie Moulder, president and CEO of MGI PHARMA, and Jim Manuso, president and CEO of SuperGen, will host the call. The live webcast can be accessed by visiting the Investor Relations section of MGI PHARMA's or SuperGen's website, www.mgipharma.com or www.supergen.com . An archived version of the call will be available via the MGI PHARMA website for seven days following the call.
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