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news.Biotech firm MGI Pharma has been asked by the FDA to undertake an additional phase III trial to support its application to market Saforis for the treatment of oral mucositis.
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The phase III trial will evaluate the efficacy of Saforis Powder in UpTec for oral suspension.
“Based upon the FDA’s request, we will be evaluating options to maximize the value of Saforis,” said Lonnie Moulder, President and CEO of MGI Pharma. “Our operating plans for next year did not anticipate a significant contribution from Saforis. We remain committed to achieving pro forma operating profitability in 2007 and executing on our core commercial and development initiatives.”
MGI Pharma is a biopharmaceutical company focused in oncology and acute care. MGI Pharma also markets Aloxi Injection, Dacogenfor Injection and Gliadel Wafer in the US.