Replies to post #361293 on Amarin Corp Plc (AMRN)

[Number sleven]

sstyles, Got it. I will see if I can find any examples where an approved drug changed it's formulation, and what it took to gain approval. If I find anything useful I will post it.
Sleven,

[Number sleven]

sstyles,
https://pubmed.ncbi.nlm.nih.gov/32008242/#:~:text=A%20505(b)(2,not%20obtained%20a%20right%20of
I think this is the regulatory path that Amarin would need to take to get an approval for a formulation change. I don't know if FDA would allow it.
Sleven,