Febuxostat tablets 80 mg

FDA Drug Profile — Febuxostat

Drug Details

Generic Name
Febuxostat tablets 80 mg
Brand Names
Febuxostat
Application Number
ANDA207293
Sponsor
Macleods Pharmaceuticals Limited
NDC Codes
1
Dosage Forms
FILM
Routes
ORAL
Active Ingredients
FEBUXOSTAT

Indications and Usage

1 INDICATIONS & USAGE Febuxostat 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. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets 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. Limitations of Use: Febuxostat tablet is not recommended for the treatment of asymptomatic hyperuricemia.