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  • williams4076 williams4076 Mar 8, 2013 12:32 PM Flag

    Vascepa and Lovaza differ chemically, new info:

    Under the new approval documents section "Chemistry Review" EPA - E is classified as a Type 1 chemical.
    A type 1 chemical is a NME. The reviewer was Martin Haber, Ph.D, the document is dated May 23, 2012. The addendum to CMC "The ONDQA Biopharmaceuticals review dated 30-MAY-2012 recommends approval. The Compliance/OMPQ/EES overall recommendation dated 25-JUL-2012 is ACCEPTABLE"

    Also on the ONDQA document pg 2/24 it states:
    "The drug substance Icosapent ethyl, an ethyl ester of the omega 3 fatty acid eicosapentaenoic (E-EPA). E-EPA is one of the two major components of the approved Lovaza, omega-3-acid ethyl esters, (Lovaza has a different applicant).

    Then it specifically describes Vascepa's capsule.

    In this approved document Vascepa is listed as Chemical Type 1 New Molecular entity.

    --------
    My DD, and this is new also:

    E-EPA is a synthetic derivate of the omega-3 fatty acid eicosapentaenoic acid (EPA).

    E-EPA IUPAC name: (Vascepa)
    Ethyl (5Z, 8Z, 11Z, 14Z, 17Z)-eicosa-5,8,11,14,17-pentaenoate
    CAS number 86227-47-6
    Molecular formula C22H34O2. Molar Mass 330.50

    Eicosapentaenoic Acid (Lovaza's EPA)
    (5Z, 8Z, 11Z, 14Z, 17Z)-5,8,11,14, 17 Icosapentaenoic acid
    CAS number 10417-94-4
    Molecular formula C20H30O2. Molar Mass 302.451

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