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