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fsulevine

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fsulevine

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Wednesday, 11/18/2020 9:42:29 AM

Wednesday, November 18, 2020 9:42:29 AM

Post# of 426566
This may have been discussed before, as I can’t read everything on the board every day, but what are the chances that, if it turns out that Hikma’s “generic” isn’t truly equivalent to Vascepa because it has too much DHA or other factors? Does the FDA test for biological equivalence? Would the FDA pull the drug or just have the label changed? How long would something lome this take and has it happened before where a generic has been proven not to be biologically/chemically equivalent?
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