Manages hyperuricemia. ANDA 207293, held by Macleods Pharms. Febuxostat.
As of Nov 14, 2026, ANDA 207293 (Febuxostat), held by Macleods Pharms, was first approved by FDA on Sep 28, 2023, with 0 approved supplements and 0 published complete response letters.
Febuxostat 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. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2023 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
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
