Replies to post #386109 on Amarin Corp Plc (AMRN)

[Number sleven]

RMB, The label is identical as it pertains to the MARINE indication. That is the indication they are approved for. The R-IT approval information is not on the label. FDA considers gv to be an AB rated generic for Vascepa in that indication. The problem is that Vascepa is the same drug for either indication. That is why it is medically legal to substitute the generic for the R-IT indication. Lovaza could not be substituted. Different drug. A self emulsifying version would be a different drug with different dosing instructions.
Sleven,

[CaptBeer]

Yes, it’s supposed to have the exact same label as the MARINE label. However, they removed the conditions of use part that said VASCEPA Has not been shown to reduce the risk for pancreatitis or cardiovascular events. Something to that effect, implying that GV has been proven. Deceiving as hell.