Amarin Corp Plc (AMRN)

[Biobillionair]

"I doubt the NDA will be rejected" As you file a NDA, RLD must be searched for compounds containing the same active ingrediates.

This is Lovaza and the active ingrediates are 1) EPA total lipids in plasma 2) Basline adjusted EPA total lipids in plasma 3) DHA total lipids in plasma 4) Baseline adjusted DHA total in plasma 5) EPA free fatty acids in plasma 6) Baseline adjusted EPA free fatty acids in plasma 7) DHA free fatty acids in plasma 8) Baseline adjusted DHA free fatty acids in plasma

The same tests have to apply for a generic Lovaza, as a NDA for Epanova. Regardless of the increase levels of both DHA & EPA with Epanova compaired to Lovaza, clinically the both drop Trigs and raise Bad cholesterol at equal levels.

Epanova is a generic end around Lovaza...period. Both have the same Free fatty acids "available at the site of drug action".

You have to perform both Bioavailability and Bioequalivance. Bioequalivance is defined in 320.1 as "the absence if a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalent or pharmaceutical alternative becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study."

How could the application be accepted?

In addition to this, Epanova must complete a 2 year rat study done on the carcinogenesis, especially since Lovaza approval was lacking this data and the EPA/DHA levels are higher. I bet they over looked this.