Manages hyperuricemia. ANDA 205443, held by Zydus Lifesciences. Febuxostat.
As of Nov 14, 2026, ANDA 205443 (Febuxostat), held by Zydus Lifesciences, was first approved by FDA on Jan 9, 2023, 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. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 9, 2023 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Sep 19, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 9, 2023 | 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
