Dr. Reddy’s Laboratories Ltd. today announced the launch of Icosapent Ethyl Capsules, 1 gram approved by the U.S. Food and Drug Administration (USFDA).
Dr. Reddy’s Icosapent Ethyl Capsules, 1 gram is approved for the following indication: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Please note that Dr. Reddy’s Icosapent Ethyl Capsules is not approved for the following 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 two 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.
Dr. Reddy’s Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120’s count.