Uloric Generics Approved
July 1, 2019 – The U.S. FDA has approved generics from Alembic Pharmaceuticals and Mylan for Takeda’s Uloric® (febuxostat). The products are 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.
The recommended starting dose with febuxostat is 40mg once daily. Patients who do not achieve serum uric acid (sUA) of less than 6mg/dL after two weeks of treatment should be increased to a recommended dose of 80mg once daily. A black box warning cautions that gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
The generic products from Alembic and Mylan will be available in 40mg and 80mg dosage strengths. Launch and pricing information are not yet available.