Zydus Lifesciences has said it has received final approval from the US Food and Drug Administration (US FDA) to market Febuxostat tablets for 40 mg and 80 mg.
According to the statement from Zydus, 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.
Zydus said the drug would be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, India. Allopurinol is a medication used to decrease high blood uric acid levels.
Febuxostat tablets had annual sales of USD 32 million in the US, according to IQVIA data for September.
The group now has got 340 approvals and has so far filed over 431 abbreviated new drug applications (ANDAs).
Leading Indian pharmaceutical company Zydus Lifesciences, formerly known as Cadila Healthcare, is a fully integrated, global health care provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain.
( With inputs from ANI )
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