Zydus gets USFDA final approval for Icosapent Ethyl Capsules

Zydus Lifesciences Limited informed to the exchanges that it 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).

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

As per the regulatory filing, Zydus’s Icosapent Ethyl Capsules are not approved for the indication as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.

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 USD 1,316 mn in the United States (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, the company informed.

Source: Media reports