MGI Pharma Saforis “Approvable” Letter Seeks More Data
This article was originally published in The Pink Sheet Daily
FDA is asking the company to conduct an additional Phase III trial to establish efficacy of oral mucositis therapy.
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MGI Pharma's Saforis (glutamine in UpTec powder for oral suspension) has a user fee date of Oct. 12 under a priority review, the firm said June 12
The myelodysplastic syndromes therapy could post $25 mil. in 2006 sales, MGI said following the May 3 approval.
The firm had planned to file the application for glutamine in the third quarter of 2005.