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Bristol-Myers Squibb UFT

Executive Summary

FDA's Oncologic Drugs Advisory Committee will review Bristol's NDA for UFT capsules (tegafur/uracil) in combination with leucovorin calcium tablets for the first-line treatment of metastatic colorectal cancer on Sept. 16. Bristol's NDA for Orzel (UFT packaged with leucovorin calcium tablets) for the same indication will not be reviewed by the committee (1"The Pink Sheet" Aug. 9, In Brief). The two NDAs contain identical clinical data and were submitted simultaneously. Leucovorin is marketed by several manufacturers

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