Zydus gets US FDA final approval for Febuxostat tablets for treating high uric acid

Zydus Lifesciences has announced that it has received final FDA approval to market Febuxostat tablets in doses of 40 mg and 80 mg. Febuxostat tablets, according to Zydus, are indicated to lower hyperuricemia (high uric acid in the blood) in gout patients who have been treated with allopurinol that did not work well or cannot be treated with allopurinol. The drug will be manufactured at Zydus' formulation manufacturing facility in Moraiya, Ahmedabad, India. Allopurinol is a drug that is used to treat high blood uric acid levels.

According to IQVIA data for September, the annual sales of Febuxostat tablets in the United States were USD 32 million. The organisation now has 340 approvals and has filed over 431 abbreviated new drug applications (ANDAs). Zydus Lifesciences, formerly Cadila Healthcare, is a leading Indian pharmaceutical company that is a fully integrated global health care provider. It has extensive domain expertise in the field of healthcare and strong capabilities across the pharmaceutical value chain.