Manages hyperuricemia. ANDA 205421, held by Alembic. Febuxostat.
As of Nov 14, 2026, ANDA 205421 (Febuxostat), held by Alembic, was first approved by FDA on Jul 1, 2019, with 1 approved supplement and 0 published complete response letters.
Febuxostat tablets are 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 tablets are not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2019 | Original application | Approved |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Jul 26, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 1, 2019 | Original application | Approved |
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
