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Takeda febuxostat review delayed

Executive Summary

FDA is continuing to review Takeda's febuxostat NDA past the Jan. 18 user fee deadline. Febuxostat is being considered for the treatment of hyperuricemia in patients with gout; an advisory committee recommended approval (12-0 with one abstention) at a Nov. 24 meeting (1"The Pink Sheet," Dec. 1, 2008, p. 5). The committee expressed concern with a potential cardiovascular signal and encouraged FDA to use its post-approval authorities to require further study. FDA also missed the Oct. 24 user fee date for Takeda's alogliptin; that review is now expected to extend until June 2009 (2"The Pink Sheet" DAILY, Dec. 29, 2008)

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