Amarin Corp Plc (AMRN)

[johngnatt]

@marjac @captbeer

I was not aware of the MSDS label that HIKMA has on its website.

https://www.west-ward.com/~/media/Files/wwsite/Products/SDS/Icosapent%20Ethyl%20Capsules%20-%20SDS.ashx

Capt, I read your write-up with great interest. This is what I have to offer. Based on what Hikma has posted publicly, the drug should be withdrawn for the market immediately. FDA need to take action RIGHT NOW.

Give the fact that Hikma claims that the maximum content
of EPA at 100% purity is 80% based on the mSDS , there is no way that this can meet the requirement for FDA bioeqivalence.
The 90% confidence interval for geometric mean bioequvalence states:
90% Confidence Interval (CI) acceptance criteria is
80.00-125.00% for the test/reference ratio for all
three parameters AUCt, AUCinf, and Cmax

If the max composition of API is 80%, there is NO WAY this can meet the 80-125% range. It is mathematical and statistically impossible

Every capsule should have exactly 1000 mg of content and API should be exactly 800 mg in each capsule.

For all practical purposes the HIKMA product is mislabeled and misbranded and need to be pulled off immediately.


Section 502 of the Federal Food, Drug and Cosmetic Act
(FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:

Its labeling is false or misleading in any particular;
It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;