The committees met jointly to discuss the results of a postmarketing cardiovascular safety study for Uloric (febuxostat) that were submitted in a supplemental new drug application (sNDA) by Takeda Pharmaceuticals (Takeda). The joint committee gave input on the cardiovascular safety and overall benefit:risk profile of febuxostat, and recommended possible regulatory actions by the FDA. A majority of the joint committee, 19 of 22 members, voted that, based upon the available data, there is a patient population in which the benefit-risk profile for febuxostat is favorable for the treatment of hyperuricemia in patients with gout.
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Earlier Event: December 17Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee
Later Event: January 16Bone, Reproductive and Urologic Drugs Advisory Committee