Manages hyperuricemia. ANDA 212924, held by Alkem Labs Ltd. Febuxostat.
As of Nov 14, 2026, ANDA 212924 (Febuxostat), held by Alkem Labs Ltd, was first approved by FDA on Dec 7, 2021, with 1 approved supplement and 0 published complete response letters.
Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablet is not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 7, 2021 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Aug 15, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 7, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
