febuxostat
Drug Details
- Generic Name
- febuxostat
- Brand Names
- Febuxostat, FEBUXOSTAT, febuxostat, ULORIC
- Application Number
- ANDA205421
- Sponsor
- Alembic Pharmaceuticals Limited
- NDC Codes
- 19
- Dosage Forms
- TABLET, COATED, TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- FEBUXOSTAT
Indications and Usage
1 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. 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. ( 1 ) Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )