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Uloric FDA Approval History

FDA Approved: Yes (First approved February 13, 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 timeline 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

Further information

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