HYDERABAD, India and Princeton, N.J.–(BUSINESS WIRE)–Dr. Reddy�s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Icosapent Ethyl Capsules, 1 gram approved by the U.S. Food and Drug Administration (USFDA).
Dr. Reddys 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. Reddys 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. Reddys Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120s count.
Please click here to see the full prescribing information along with the approved indication for Dr. Reddys Icosapent Ethyl Capsules: https://www.drreddys.com/pi/icosapent-ethyl-1g-pi.pdf.
Important Safety Information: Icosapent Ethyl Capsules, 1 Gram
What Important Information Should I Know About Icosapent Ethyl Capsules, 1 Gram?
Who Should Not Use Icosapent Ethyl Capsules, 1 Gram?
What Should I Tell My Healthcare Provider Before Taking Icosapent Ethyl Capsules, 1 Gram?
Before taking Icosapent Ethyl Capsules, tell your doctor if you:
Provide your doctor with a complete list of medications you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements. Icosapent Ethyl Capsules can interact with certain other medicines that you are taking.
Tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).
What Are the Possible Adverse Reactions of Icosapent Ethyl Capsules, 1 Gram?
Call your doctor or get emergency help right away if you develop:
If you have a liver condition and are taking Icosapent Ethyl Capsules, your doctor should do blood tests during treatment.
The most common adverse reactions include:
Please refer to the Package Insert for full prescribing information for Icosapent Ethyl Capsules.
These are not all of the possible side effects of Icosapent Ethyl Capsules. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddys Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com or contact the US FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/safety/medwatch.
Indication and Usage for Icosapent Ethyl Capsules, 1 Gram
Please note that Dr. Reddys 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.
Contacts
INVESTOR RELATIONS
AMIT AGARWAL amita@drreddys.com
MEDIA RELATIONS
USHA IYER
ushaiyer@drreddys.com
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