Replies to post #302912 on Amarin Corp Plc (AMRN)

[Whalatane]

Agree. FDA would require the generics to disclose AFib risk ... even if the indication on label was only for treating Tg’s > 500

However this risk wasn’t known till the R-It trial ( correct if wrong ) and so they would have to update their label with R-It risk info

Hard to see how the generics avoid inducing to infringe by using data from an indication ( The R-It indication ) that is patent protected .

Trying to understand this ... but either way .... as Downtownguy ? posted .... definitely raises the risk for Generics if they launch

This was the original PDF for Vascepa I believe ....Marine indication . Was updated in 2013 I think

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf

Kiwi