FDA approves Uloric generic for chronic hyperuricemia management in gout - Healio

January 23, 2024

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Key takeaways:

  • The FDA has approved generic febuxostat 40 mg and 80 mg tablets for managing chronic hyperuricemia.
  • The annual U.S. market for the drug is estimated at $27 million, according to its manufacturer.

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.

Generic FDA News infographic
The FDA has approved an abbreviated new drug application for a generic version of Uloric, according to a press release.

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 (indomethacin, Zyla Life Sciences) oral suspension for the treatment of ankylosing spondylitis and other conditions.

IQVIA MAT data from November 2023 estimated annual U.S. sales of Uloric at $27 million, according to the release from Lupin.

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