Febuxostat

Manages hyperuricemia. ANDA 210292, held by Regcon Holdings. Febuxostat.

As of Nov 14, 2026, ANDA 210292 (Febuxostat), held by Regcon Holdings, was first approved by FDA on Dec 30, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 30, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 30, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Febuxostat40MG · tablet;oral	Febuxostat	Rx
Febuxostat80MG · tablet;oral	Febuxostat	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 29, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Dec 30, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210292
Drugs@FDA: Overview at FDA
Company: Regcon Holdings

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