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Ethyl eicosapentaenoic acid (E-EPA, icosapent ethyl), sold under the brand name Vascepa among others, is a medication used to treat dyslipidemia [4] and hypertriglyceridemia. [3] It is used in combination with changes in diet in adults with hypertriglyceridemia ≥ 150 mg/dL. Further, it is often required to be used with a statin (maximally ...
Amarin Corporation. Amarin Corporation is an Irish-American biopharmaceutical company founded in 1993 and headquartered in Dublin, Ireland and Bridgewater, New Jersey. [1] The company develops and markets medicines for the treatment of cardiovascular disease. It has developed the drug Vascepa (AMR-101), a prescription grade omega-3 fatty acid.
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Omega-3 acid ethyl esters are used in addition to changes in diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. [10] In the European Union and other major markets outside the US, omega-3 acid ethyl esters are indicated for hypertriglyceridemia by itself, or in combination with a statin for people with mixed dyslipidemia.
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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
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