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  2. Ethyl eicosapentaenoic acid - Wikipedia

    en.wikipedia.org/wiki/Ethyl_eicosapentaenoic_acid

    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 ...

  3. Omega-3 acid ethyl esters - Wikipedia

    en.wikipedia.org/wiki/Omega-3_acid_ethyl_esters

    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.

  4. Amarin Rises on Priority Review for Vascepa Label Expansion - AOL

    www.aol.com/news/amarin-rises-priority-review...

    Amarin's (AMRN) label expansion application for hypertriglyceridemia drug, Vascepa, gets priority review from the FDA.

  5. 3 Lessons From Amarin's Failures in 2013 - AOL

    www.aol.com/news/2013-12-05-3-lessons-from...

    The maker of fish oil drug Vascepa, a treatment for severe hypertriglyceridemia (triglyceride levels equal to or higher. It's been a brutal year for Amarin , which has lost more than 76% of its ...

  6. 3 Things to Watch at Amarin's Advisory Committee Meeting - AOL

    www.aol.com/2013/10/15/3-things-to-watch-at...

    Amarin faces the firing squad tomorrow when the Food and Drug Administration's advisory committee reviews its lipid-lowering drug Vascepa. The drug is already approved for patients with extremely ...

  7. Amarin Corporation - Wikipedia

    en.wikipedia.org/wiki/Amarin_Corporation

    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.

  8. Case 1:15-cv-03588-PAE Document 73 Filed 08/07/15 Page 1 of 71

    highline.huffingtonpost.com/miracleindustry/...

    between these provisions and the First Amendment. The Court then reviews the FDA’s evaluation of Vascepa and the basis for its decision to not approve it for the off -label use at issue here. The Court then reviews this lawsuit and Amarin’s application for preliminary relief. A. The Statutory and Regulatory Framework 1. Brief History of the ...

  9. The Food and Drug Administration usually takes about a month to make a decision about how long a drug will have exclusivity. Unless you're Amarin . Then it takes about 19 months. And the answer ...

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