Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Febuxostat Tablets, 40 mg and 80 mg (USRLD: Uloric Tablets).
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. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
The group now has 340 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
