Saforis
Generic name: glutamine
Treatment for: Mucositis
MGI Pharma Receives Approvable Letter for Saforis (Glutamine) Powder in UpTec for Oral Suspension
MINNEAPOLIS, October 12, 2006 -- MGI PHARMA, INC., a biopharmaceutical company focused in oncology and acute care, today announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Saforis (glutamine) Powder in UpTec(TM) for Oral Suspension, an investigational therapy for the treatment and prevention of oral mucositis. The FDA has requested an additional phase 3 trial to evaluate the efficacy of Saforis in the proposed indication.
"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."
Posted: October 2006
Related articles
- Saforis NDA Accepted by U.S. FDA for Priority Review - June 12, 2006
- MGI Pharma Announces Submission of Saforis NDA - April 13, 2006
Saforis (glutamine) FDA Approval History
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