Lupin Gets USFDA Nod to Market Generic Hyperuricemia Treatment Drug

Pharma major Lupin Ltd. on Thursday said it has received approval from the U.S. health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout.

The approval by the U.S. Food and Drug Administration is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing.

The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) 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 had estimated annual sales of $27 million in the U.S., Lupin said citing IQVIA MAT November 2023 data.