Hyderabad, Dr. Reddy’s Laboratories Ltd on Tuesday 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, Hyderabad-based Pharmaceutical giant said in a release here.
It may be noted here 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.
The effect of Icosapent Ethyl Capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined, it said.Dr. Reddy’s Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120’s count.