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Dr. Reddy Laboratories Co., Ltd. ((BSE: 500124, NSE: DRREDDY, New York Stock Exchange:RDY, NSEIFSC: DRREDDY and its subsidiaries are collectively referred to as “Dr. Reddy’s”)) today announced the launch of Icosapent Ethyl Capsules, 1 gram has been approved by the US Food and Drug Administration (USFDA).
Dr. Reddy’s Icosapent Ethyl Capsules 1 gram is approved for the following indications: as a dietary aid to reduce triglyceride (TG) levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia.
Please note that Dr. Reddy’s Icosapent ethyl capsules are not approved for the following indications: as an adjuvant therapy to the maximum tolerance of statin therapy to reduce myocardial infarction, stroke, and coronary artery blood in adult patients with elevated triglycerides Unstable angina pectoris (TG) level (≥ 150 mg/dL) and established cardiovascular disease or diabetes and two or more other risk factors for cardiovascular disease.
Use restrictions: The effect of Icosapent Ethyl Capsules on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Dr. Reddy’s Icosapent Ethyl has 1 gram capsules and the number of bottles is 120 bottles.
Please click here for complete prescribing information and approved indications for Dr. Reddy’s Icosapent ethyl capsules: https://www.drreddys.com/pi/icosapent-ethyl-1g-pi.pdf.
Important safety information: Icosapent Ethyl Capsules, 1 g
What important information should I know about Icosapent Ethyl Capsules, 1 gram?
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Icosapent Ethyl is associated with an increased risk of arrhythmias (atrial fibrillation or atrial flutter) requiring hospitalization
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Potential allergic reactions in fish and/or shellfish allergy patients
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If the following conditions occur, please stop and seek medical attention…
The full story on Benzinga.com
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