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Amarin Corporation plc Message Board

  • brandonuk03 brandonuk03 Sep 20, 2012 5:18 PM Flag

    FDA generic Lovaza guidance- where is it?

    Anyone have a link? I keep hearing about the FDA guidance issued today on Lovaza generics, but can't find it. TIA.

    Sentiment: Strong Buy

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    • Do a search on the fda website for Omega-3-Acid Ethyl Esters and you'll see a PDF for guidance

      • 1 Reply to ekimb48
      • Here's the heading for the guidance........

        Draft Guidance on Omega-3-Acid Ethyl Esters
        This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's)
        current thinking on this topic. It does not create or confer any rights for or on any person and does
        not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies
        the requirements of the applicable statutes and regulations. If you want to discuss an alternative
        approach, contact the Office of Generic Drugs.
        Active ingredient: Omega-3-Acid Ethyl Esters
        Form/Route: Capsule / Oral
        Recommended studies: 1 In Vitro Study or 2 In Vivo Studies

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