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Uloric Approval History

  • FDA approved: Yes (First approved February 13th, 2009)
  • Brand name: Uloric
  • Generic name: febuxostat
  • Dosage form: Tablets
  • Company: Takeda Pharmaceutical Company Limited
  • Treatment for: Gout

Uloric (febuxostat) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

Development History and FDA Approval Process for Uloric

Feb 17, 2009Approval FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
Jan 20, 2009Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date
Nov 25, 2008Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
Dec 15, 2004TAP Submits New Drug Application for Febuxostat for the Management of Hyperuricemia in Chronic Gout

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