Zydus Lifesciences Ltd on Tuesday said it has received final approval from the US health regulator to market its generic version of Febuxostat tablets used to treat high uric acid in the blood.
The approval granted by the US Food and Drug Administration (USFDA) to market Febuxostat tablets is for strengths of 40 mg and 80 mg, the company said in a regulatory filing.
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya in Ahmedabad, it added.
The company said Febuxostat tablets are indicated to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol.
Febuxostat tablets had annual sales of USD 32 million in the US, Zydus said, citing IQVIA September 2022 data.