MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG) Release: Dacogen(TM) (Decitabine) Injection Complete Response Accepted For Review By U.S. FDA
12/16/2005 12:15:38 PM
MINNEAPOLIS & DUBLIN, Calif.--(BUSINESS WIRE)--Dec. 15, 2005--MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) 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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