FDA approves Uloric generic for chronic hyperuricemia management in gout

The FDA has approved an abbreviated new drug application for Lupin Limited’s generic febuxostat 40 mg and 80 mg tablets, according to a press release from the manufacturer.
The tablets, a generic version of Uloric (febuxostat, Takeda), are indicated for chronic hyperuricemia management in adult patients with gout who have not responded to, or cannot take, allopurinol.
The generic febuxostat tablets will be manufactured at Lupin’s facility in Pithampur, India.
The announcement comes on the heels of the FDA approval of ANI Pharmaceuticals’ generic version of Indocin

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