Replies to post #263145 on Amarin Corp Plc (AMRN)

[moonotaur]

Surely the FDA knows that any generic of vascepa is going to be written off label for the reduce-it indication, so I think the FDA has grounds to tie the two together as if the generics were being approved for reduce-it as well.

In this case, without the exact same manufacturing process (which Amarin has patented), the FDA cannot be 100% confident of bio equivalency and should require further studies.