Amarin Corp Plc (AMRN)

[rosemountbomber]

Marzan, I hesitate to chime in for two reasons (but it sounds like I will anyways). First your question was directed to JRoon and secondly what I might suggest would run counter to what North suggests, and I highly respect and value his knowledge, which is far greater than mine when it comes to these things. But let me throw out the thoughts that are bouncing in my head wrt this.

The way I understand it, the FDA does definitely have the ability and power to withdraw ANDAs approvals. But to me it sounds like it is when they find fraudulent action and data with respect to the ANDA application. It appears that even in that situation some people are disappointed that the FDA seems to have a history of being very reticent to use its power in this regard. Here is a STAT article from a year ago where it is clear that fraudulent data was submitted to the FDA but the FDA is giving these companies (mostly Generics) a pass or extension to resubmit or whatever.

https://www.statnews.com/2024/08/12/fda-withdraw-approval-400-plus-tainted-drugs/