Re: Questions re generic IPE vs brand Vascepa
Yes - when the details of Hikma's GV came out and initially made no sense I weighed two of my 0.5 g caps of V, they weighed 1.45g combined. Label says they contain 0.5 g of IPE, so the capsule is 33% of total weight - I was really surprised about that. For GV to meet bioequivalency they have to have at least 90% of the brand name's active ingredients - I believe I've previously posted about this, something called "The myth of the 80%-120% rule" or something similar, so I'm assuming a 1 g cap of GV also weighs ~ 1.5 g - that guy on Youtube measured V and GV, cut them open to smell them, but he didn't weigh them to compare. FDA's AB rating means it's therapeutically equivalent to brand name - docs will rightly assume that GV should work just as well for the R-IT indication - I mean how could they not? There's no logical reason to believe a generic the FDA says is equivalent to the brand should work for TGs but not for CVD - that's partly what got Teva in trouble with GSK - the promoted that generic drug for patented uses (CHF?) and docs prescribed it for that use.