Amarin Corp Plc (AMRN)

[Biobillionair]

Yoyo
First the chemical name for Vascepa is Icosapent Ethyl, this happened also be the chosen name the USP or U.S. Pharmacopeidial Covention chose. Notice when you read MAPP 5021.1 how many times USP is referenced. The USP changed it's Monograph naming policy and CDER is applying this change to their policy's. So in the eyes of the USP and the FDA Vascepa is Icosapent Ethyl. Yes, it does have an ester linked covalent bond but the naming of Vascepa doesn't include "ester".

The USP's Monograph name for Lovaza is Omega-3-Acid Ethyl Esters Capsules.
http://www.usp.org/usp-nf/official-text/errata-table?mono_num=2609

So not only does the FDA consider Lovaza two separate chemicals with two individual draft guidances, but the USP also considers the two separate with two different mongraph names. This is also one of the reasons why this has been delayed so long. 5021.1 was posted and effective 2-20-2013.

5021.1 excludes esters like Omega 3 acid Ethyl esters, but includes Icosapent Ethyl.

My interpretation of reading the documents I have found.

Icosapent Ethyl has many synonyms which makes this topic confusing, it's not an accident the FDA & USP are chosing their words carefully in all policy's related to Lovaza and Vascepa.

I hope this answers your great question?

Williams