Amarin Corp Plc (AMRN)

[Biobillionair]

First it's Icosapent Ethyl;). The FDA was not prepared to make the decision. In 9-2012 they approved a therapeutic equivalence for Ethyl Ester of Omega 3, this was after Vascepa approval. Icosapent Ethyl therapeutic equivalence document came out 4-2013. These decisions don't directly have anything to with NCE except differentiate the difference between Lovaza and Vascepa. The two documents clearly list two different chemicals.
Other Prodrug that have been approved have also mistakenly been given NME only for the FDA to go back and correct this mistake. Example, Emend decision.