Last Updated on October 11, 2024 by The Health Master
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 (as of 31st December 2022) ANDAs since the commencement of the filing process in FY 2003-04.
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