MGI Drug Needs New Trial

The company gets conditional approval from the FDA for the oral mucositis drug Saforis.
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MGI Pharma


received conditional approval from the Food and Drug Administration for its proposed oral mucositis drug Saforis.

The FDA issued what's called an approvable letter, telling MGI it will clear the drug after it conducts an additional late-stage trial to prove the treatment's effectiveness. If the agency is satisfied with the results, it would then grant full approval for Saforis.

Oral mucositis is a condition caused by chemotherapy in which patients develop dryness and redness in the mouth and painful ulcers in the mouth and throat, making talking, eating and drinking difficult.

Shares of MGI were up 2.7% to $17.92.