Global pharma major Lupin Limited on Thursday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Febuxostat Tablets, 40 mg and 80 mg.
According to the company’s press statement, the approval has been granted to market a generic equivalent of Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
Febuxostat Tablets, 40 mg and 80 mg, 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.
Febuxostat Tablets (RLD Uloric) had estimated annual sales of USD 27 million in the U.S. (IQVIA MAT November 2023).
