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Author: Admin | 2025-04-28
In a close approximation to the brand name drug. But the blood levels of the generic do not have to be identical to the original medicine.The Budeprion XL 300 Debacle:One example of reverse-engineering involved the antidepressant Wellbutrin XL 300. A generic manufacturer wanted to bring out a similar timed-release version. Although the patent on the API had expired, there was still an active patent on the membrane technology that allowed the active ingredient, bupropion, to be absorbed slowly into the body.The generic manufacturer had to come up with a different release process. It chose a matrix formulation. The drug was not absorbed in a similar manner as the original brand name medicine.Patients who were switched from Wellbutrin to the generic version complained of symptoms such as dizziness, nausea, headaches, insomnia, tremor, irritability and digestive problems. In addition, some found that their depression returned.We badgered the FDA for five years before the agency admitted that the generic Budeprion XL 300 was not “bioequivalent” to the brand name Wellbutrin XL 300. Here is a link to that sad saga in the FDA approval process.Popular Generic Antidepressant RecalledEven though Budeprion XL 300 disappeared from the market, Budeprion XL 150 remains. The FDA considers it “the same as” the brand name Wellbutrin XL 150. Take a look at this graph comparing absorption of the generic formulation (Budeprion XL 150) to the brand name antidepressant Wellbutrin XL 150.The generic formulation (Budeprion XL 150, aka bupropion) reaches peak blood levels in less than 2 hours (blue line). The brand name Wellbutrin XL 150 doesn’t reach peak blood levels until nearly six hours after it was swallowed. The FDA maintains that the generic form of bupropion has “performance characteristics” that are “the same as” the brand name, even though they are absorbed into the bloodstream quite differently. But that may not dovetail with how patients feel.A reader shared this experience regarding generic bupropion with us:“When my manufacturer of this generic [antidepressant] drug was changed, I started having massive PVCs [premature ventricular contractions]. When I went back on my original manufacturer of this drug, the PVCs stopped! The pill that causes me to have PVCs is imprinted with: A 101.”Another reader offered this:“Are you still running tests on generic bupropion? I have a feeling mine (150XL) (A101) is not working properly. I noticed a significant change in mood and return of symptoms after being switched to it from a different 150XL generic.”The FDA has not responded yet to our concerns about this situation.What About Authorized Generic Drugs?According to the FDA, authorized generic drugs are exactly the same as the brand name. The only difference is that they don’t have the brand name on the label. Sometimes they are even made on the same production line as the brand.Please note the subtle difference in wording. The FDA says that generic drugs are “the same as” brand name drugs. The FDA states that authorized generic drugs are :“…the exact same drug product as the branded product.”An Analogy:We will let you
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