Captain, That is what FDA requires. In the thinking of FDA the generic companies can't put the CVD disclaimer on the label. FDA rated the product an A/B equivalent. As far as FDA is concerned the two products are the same. FDA has no concerns about the little stuff.(like patent law) Sleven,
The Court: But if what you're approved for is severe hypertriglyceridemia or whatever it is :-), why don't you just say that rather than hyperglycemia? :-) Mr. Klein "I don't know why" LOL
Capt....definitely agree with you there. To the best of my knowledge there is no data showing that icosapent ethyl reduces cardiovascular events in patients with trigs >500. Should still be on their label for their intended indication.