FDA Admits Generic Wellbutrin Isn’t An Equivalent After Years Of Complaints

For years patients have said the generic Wellbutrin doesn’t work as well as brand name. The FDA finally took action against manufactures of the generics, admitting Clinical Trials were not performed on 300 mg Extended Release tablets. Follow up test found discrepancies in Bioeqivalence. The FDA holds responsibility as well, they are accountable to the public. The FDA requires all companies who manufacture medication to prove medication is safe, effective…equivalent or not for generics.  This process can take years. The over looked, the lack of testing on higher mg caused many patients to take ineffective medicine suffering higher levels of depression.

Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies

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. This methodology was based on FDA’s guidance at the time the products were approved. 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.

http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm322161.htm

I subscribe to FDA Updates which provide valuable information.There is a section on each update showing who needs the information. When patients are on the list I ask who is contacting the patients? No-one. It’s a reminder you have to participate in your mental health care which includes staying informed. The daily updates can clog the email, I find most weekly updates valuable.

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