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FDA Announces Removal of Generic Wellbutrin XL 300 mg

FDA Announces Removal of Generic Wellbutrin XL 300 mg

Part of the process of achieving Food and Drug Administration approval for prescription medication is the clinical trial. During a clinical trial, the drug will be tested multiple times to determine whether it works and if it has any side effects. To determine this information, the drug is tested against a placebo so accurate comparisons can be made, and a placebo, of course, is simply nothing more than an inert pill. But it’s important to realize that while placebos are meant to do absolutely nothing, prescription drugs are actually supposed to do something. Otherwise, why would the FDA ever bother approving them?

That’s a question that many people are asking after it was announced that Impax Laboratories and Teva Pharmaceuticals announced the removal of Budeprion XL 300 mg, a generic version of the popular prescription depression medicine Wellbutrin XL 300 mg, from the market. The reason for the market removal is that the drug is not “therapeutically equivalent” to Wellbutrin XL 300mg.

It turns out, according to Forbes, that the FDA took at least four years before conducting its own study on the legitimacy of the drug and the actual dangers of the side effects, despite many complaints from patients since the generic form of the drug was first approved in 2006. Additionally, the FDA received the results in August and didn’t release them publicly until October 3. In a press release, the FDA admitted that the approval process it used for generic versions of Wellbutrin XL 300 mg is “no longer appropriate” going forward:

"FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product.

FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products."

This may be just the tip of the iceberg as it turns out that Wellbutrin XL 300 mg isn’t the only generic drug to have reached the market under the approach which is “no longer appropriate” for determining bioequivalence.  Accordingly, the FDA has requested that other generic drug companies conduct bioequivalence studies and submit the results by March 2013.  So stay tuned, we may be in for some more alarming news about other generics.



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