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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer

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From: Icebrg12/15/2005 4:45:41 PM
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Dacogen(TM) (Decitabine) Injection Complete Response Accepted for Review by U.S. FDA

Thursday December 15, 4:37 pm ET

MINNEAPOLIS and DUBLIN, Calif., Dec. 15 /PRNewswire-FirstCall/ -- MGI PHARMA, INC. (Nasdaq: MOGN - News) and SuperGen, Inc. (Nasdaq: SUPG - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Companies' resubmission as of November 15, 2005 as a complete response to the Approvable Letter for Dacogen(TM) (decitabine) injection for myelodysplastic syndromes (MDS). The resubmission has been classified by the FDA as a Class 2 response, and the FDA has established a user fee goal to review this response by May 15, 2006.
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