Amarin Corp Plc (AMRN)

[HDGabor]

BB & sts66,

I think no direct relation between labeling and patent use code.

I am 100% sure, that Epanova label will be for >500. Something like this (or exactly):

Epanova is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (=>500 mg/dL) hypertriglyceridemia.
Limitations of Use:
• The effect of Epanova on the risk for pancreatitis has not been determined.
• The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined.

Patent use code: The brand manufacturer submits the use code to the FDA as part of Form 3542, and the FDA accepts the code without verifying its accuracy.

The description of the patent use code itself means nothing (just see Lovaza's PUC: U - 822: USE IN LIPID MANAGEMENT) it's just a description.