febuxostat
Drug Details
- Generic Name
- febuxostat
- Brand Names
- FEBUXOSTAT, febuxostat, ULORIC, Febuxostat
- Application Number
- ANDA213069
- Sponsor
- Lannett Company, Inc.
- NDC Codes
- 22
- Dosage Forms
- TABLET, POWDER, TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- FEBUXOSTAT
Indications and Usage
1 INDICATIONS AND USAGE Febuxostat Tablets are 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. Febuxostat Tablets are 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. ( 1 ) 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. ( 1 )