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marjac

01/25/22 10:00 AM

#367370 RE: rafunrafun #367281

Raf, thank you for posing the issues in such a clear fashion.

From a litigator's point of view, the clear-cut case would be if the generic was not the bioequivalent of the real Vascepa, specifically, a clinically and medically inferior knock-off. From what you say, that appears not to be the case.

Yet it is interesting and baffling to me as to how it can be the bioequivalent, yet give off the rotten fish odor, unless the answer lies in the composition of the capsule.

Note that the product could meet FDA standards but still violate consumer fraud laws, if the generic manufacturer omits material facts about the product from consumers, where knowledge of those facts would affect the consumer's decision to use the product.
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ziploc_1

01/25/22 11:58 AM

#367402 RE: rafunrafun #367281

The FDA has a history of not having the issue of bioequivilentcy high up on its agenda...It will take a concerted effort from Amarin to bring the factors you mention to the attention of the FDA and possibly to the public...Scientific evidence from Dr. Mason or from other scientists would certainly be a help in doing this.