On February 19, 2009, the US Food and Drug Administration (FDA) approved the licensing of febuxostat for the treatment of hyperuricemia in patients with chronic gout. This is the only approved indication for the drug at this time. Febuxostat will be marketed under the trade name Uloric and is manufactured by Takeda Pharmaceuticals. Links to [...]
FDA Arthritis Drug Advisory Committee Recommends Approval of Febuxostat for Treatment of Hyperuricemia of Gout
At their November 24, 2008 meeting, the FDA Arthritis Drug Advisory Committee heard updated efficacy and safety data for febuxostat for the treatment of gout-associated hyperuricemia. The committee’s recommendation was carried on a vote of 12 to 0. Final FDA approval of the drug is pending; however, FDA approval generally follows the recommendations of the advisory committee.