VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
And:
The effect of VASCEPA on cardiovascular mortality and morbidity in patients has not been determined.
Are contradictory, are they not? In any case, the bold red part of the first statement is what I believe the FDA is saying cannot be on the label until R-IT is finished and the 2nd claim disappears.
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