Dr Reddy’s Laboratories Ltd has launched Icosapent Ethyl capsules in the US market after approval from the US Food and Drug Administration (US FDA).
Dr Reddy’s Icosapent Ethyl Capsules, 1 gram is approved to be used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.
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“However, it is not approved to be used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularisation, and unstable angina requiring hospitalisation in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease,'' the Hyderabad-based company said in a release.
The effect of Icosapent Ethyl Capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined, it added.