MoneyWorks4Me

Zydus Lifesciences gets USFDA’s final approval for Febuxostat Tablets

10 Jan 2023 Evaluate

Zydus Lifesciences 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 $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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

Peers
Company Name CMP
Sun Pharma. Inds. 1745.00
Dr. Reddys Labs. 1242.00
Cipla 1331.00
Lupin 1953.75
Zydus Lifesciences 1113.00
View more..