Replies to post #13443 on Amarin Corp Plc (AMRN)

[Whalatane]

DRRC
From memory ...Mochida applied for approval to sell Epadel in the US several yrs ago but the FDA required them to run a trial with NASH patients .
I think they ran into problems recruiting for that trial then AMRN arrived with Phase 3 data , patents and FDA approval and I think that pretty much ended it for Epadel in the US
Akanz

[sts66]

Decided to answer my own question and looked it up - appears that Epadel would have no problem selling in the US, doesn't need any sort of FDA review or approval since it's already a known ingredient in dietary supplements:

http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.htm#FDA_role

What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

So they can import and sell Epadel in the US whenever they want - however, they CANNOT market it for medical use, cannot claim it can or will lower TGs, but if they violate those rules on advertising they'll get a slap on the wrist and have to change the label. Still, given it's cost (more than equivalent dose of Vascepa), it's not a threat here, and may not be a threat anywhere else either. OTOH, don't expect AMRN to attempt to get marketing approval in Japan either ;-)