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OctoberOn October 3, 2005, MGI PHARMA announced it completed its previously announced (July 21, 2005) acquisition of Guilford Pharmaceuticals, a biopharmaceutical company engaged in the research, development and commercialization of drugs that target the acute care market. With this transaction, MGI PHARMA added Gliadel® Wafer (polifeprosan 20 with carmustine implant) to its portfolio of marketed products, Aquavan® (fospropofol disodium) Injection to its clinical development pipeline, additional oncology and acute care product candidates, enhanced R&D capabilities and an acute care field organization. |
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SeptemberOn September 1, 2005, MGI PHARMA received an approvable letter from the U.S. Food and Drug Administration for Dacogen™ (decitabine) for Injection for the treatment of myelodysplastic syndromes(MDS). The letter provides that Dacogen 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. |
