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Enbrel & Remicade potential re-labeling

Executive Summary

FDA is considering re-labeling Immunex' Enbrel and J&J's Remicade in light of recent reports of three Enbrel patients and 17 Remicade patients with tuberculosis. The agency presented data on post-marketing events at the American College of Rheumatology's annual scientific meeting in Philadelphia Oct. 30. FDA is discussing the issue with both companies
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PS036844

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