Manages hyperuricemia. NDA 21856, held by Takeda Pharms USA. Febuxostat.
As of Nov 14, 2026, NDA 21856 (Uloric), held by Takeda Pharms USA, was first approved by FDA on Feb 13, 2009, with 9 approved supplements and 0 published complete response letters.
ULORIC 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.
| Feb 21, 2019 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2017 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2009 | Original applicationNew molecular entity · Standard review | Approved |
| Uloric40MG · tablet;oral | Febuxostat | RxReference drug |
| Uloric80MG · tablet;oral | Febuxostat | RxReference drug |
| Apr 17, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Feb 21, 2019 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Feb 6, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Aug 15, 2017 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 12, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 23, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 1, 2012 | Supplement 6Labeling | Approved | |
| Jan 28, 2011 | Supplement 3Labeling | Approved | |
| Feb 13, 2009 | Original applicationNew molecular entity · Standard review | 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
