Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Icosapent Ethyl Capsules, 0.5 g and 1 g (USRLD: Vascepa Capsules, 0.5 g and 1 g).
Limitations of use: The effect of Icosapent Ethyl Capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Icosapent Ethyl Capsules, 0.5 g and 1 g had annual sales of $1,316 million in the US (IQVIA MAT Feb. 2023).
The group now has 365 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
(*as of 31st December 2022)