Replies to post #268347 on Amarin Corp Plc (AMRN)

[dmlcento]

https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs

I don't see anything in this FDA write-up that says that a generic drug has to address an unmet need. I do, however, see that there is a requirement that the container the drug is delivered in must be appropriate. I thought that Amarin has a patent for its encapsulation method. If so, is there a way that the FDA halts this due to the capsule being suggested or used by the generics?

[couldbebetter]

CaptBeer, Please see Raf's post#268067 regarding a study from the
University of Zurich that shows C-19 causes inflammation of the
endothelial cells of blood vessels and various organs such as the
heart, lungs, and brain. This indicates that the virus may cause
damage to the Cardiovasular System. Vascepa may be the best treatment
option available...and is already FDA approved so no study should be
required for doctors to treat. John Thero or Dr Bhatt should be
discussing this with Mike Pence, the CDC, VA, and medical commands...
that a treatment option for the inflammatory damage caused by the
virus may be ameliorated by prescribing Vascepa.

Would hope to see your comments on this!

[sts66]

I've been talking about the stability/shelf life issues the generics might face for over a year - can you point to an FDA doc that specifically says "Generic versions of branded products must demonstrate that their products do not deteriorate faster than the branded versions."

And your source for this? "This usually requires months of testing." I also wonder whether generics must show stability over a range of temperatures.