Bristol UFT/Orzel
Executive Summary
NDAs for UFT (tegafur/uracil) capsules for use with leucovorin in the first-line treatment of advanced colorectal cancer and Orzel (UFT capsules packaged with leucovorin tablets) are withdrawn. At a March 3 securities analyst conference, Bristol had said FDA's review was likely to be delayed (1"The Pink Sheet" March 13, p. 27). Bristol will refile the applications after FDA examines new data analyses