3 ms·

I've read and heard that FDA rules allow generic to get 80% - 125% of the active ingredient into the bloodstream as the original drug. Of course the manufactur

I've read and heard that FDA rules allow generic to get 80% - 125% of the active ingredient into the bloodstream as the original drug. Of course the manufacturing tolerances are much better than that, so makers often put just enough to make the 80%.

maxerickson 10y ago
My links says The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same. So there should be some specific FDA regulation someone can find that explains what they mean by the same there. I can certainly believe that the regulation would specify a range, but I'd like to see it. My link also contains a suspiciously pertinent paragraph when you consider that 125-80=45: FACT: FDA does not allow a 45 percent difference in the effectiveness of the generic drug product. It's not clear that they would actually be referring to the same meaning of 45% but it is at least an amusing coincidence and there is some chance the FDA is frustrated with whatever it is you read.