Following approval through the Mutual Recognition Procedure of theEuropean Union plus Norway and Iceland in October 2000, Bristol-Myers Squibb has begun sales in the UK of UFT (tegafur/uracil), in combination with Leucovorin (calcium folinate), for the first-line treatment of metastatic colorectal cancer.
UFT was originally developed by Taiho Pharmaceutical of Japan and is already available in a number of markets including Japan, several Asia-Pacific countries and Spain, the reference state for the European Medicines Evaluation Agency's mutual recognition scheme, where it is indicated for several solid tumor types, including colorectal, breast and gastric cancer. Approvals are pending in Austria, Greece, Italy and Luxembourg.
In March this year, B-MS withdrew its New Drug Application for UFT in the USA, and the withdrawal also applied to B-MS' co-packaged product Orzel (UFT capsules plus leucovorin calcium tablets). The firm said at the time that it chose to withdraw and resubmit these applications in order to afford the FDA additional time to review new analyses of existing data (Marketletter May 1, 2000).
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