Amarin Corp Plc (AMRN)

[Biobillionair]

I think you'll find the answer to the petition in the new Salt Document and CDER presentation. It's effective 2-20-2013.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM340273.pdf

Now review the 3-6-2013 Summary Review of Approval and not the definition of Lovaza.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000SumR.pdf

Finally look at the CDER implication presentation on how to apply the new salt document. Specifically note "Esters are excluded from this policy"
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341171.pdf

USP also changed Icosapent Ethyl to Icosapent Ethyl Capsule 2-20-2013
http://www.usp.org/search/site/icosapent

Lovaza's Active Moiety is Ethyl Esters of Omega 3's (now in bold at the FDA site)
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Vascepa's active moiety is Icosapent Ethyl Capsule