MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG): Approvable Letter Received From The FDA For Dacogen(TM) (Decitabine) Injection For The Treatment Of MDS; FDA Asks For More Info
10/19/2005 5:09:12 PM
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.
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