Manages hyperuricemia. ANDA 205414, held by Hikma. Febuxostat.
As of Nov 14, 2026, ANDA 205414 (Febuxostat), held by Hikma, was first approved by FDA on Oct 15, 2019, with 1 approved supplement and 0 published complete response letters.
Febuxostat Tablets are 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. Limitations of Use: Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2019 | Original application | Approved |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Jul 26, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 15, 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
