Manages hyperuricemia. ANDA 205374, held by Dr Reddys. Febuxostat.
As of Nov 14, 2026, ANDA 205374 (Febuxostat), held by Dr Reddys, was first approved by FDA on Oct 22, 2020, 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 tablets are not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2020 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Aug 9, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 22, 2020 | 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
