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FDA Generic Drug Approval Process Called into Question

Ongoing consumer complaints involving the generic version of the popular antidepressant Wellbutrin, have called into question the generic drug approval process of the Federal Drug Administration (FDA). The agency, charged with ensuring public safety and approval of all consumer drugs acknowledges problems with the way it approves some generic drugs.

Generic versions of Wellbutrin XL began to receive approval in 2006. The FDA approved a version manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals in both a 150mg dose and a 300mg dose. This version is known as Budeprion XL 300 mg.

Immediately after approval of the Impax/Teva product, issues began to surface with the 300 mg version. Hundreds of patients who switched from the name-brand version to the generic began to report reduced efficacy of the new product.

generic medicationIn 2007, hundreds of patients began to complain of side effects when switched to the generic version. Teva was asked to perform a study. However, three years later, in 2010, was still unable to provide further data. Eventually, the FDA undertook its own study that it completed in 2012, more than five years after complaints began. The study showed that the generic version failed to match the effectiveness of Wellbutrin XL 300 mg. It did not release bupropion into the blood at the same rate and to the same extent as the brand name.

In a recent letter, the FDA acknowledges that it approved the 300 mg version by extrapolating data from the 150 mg version. Once testing was conducted, five years after the initial problems began to surface, the FDA concluded “Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg. “

Risks to consumers can be high due to the nature of the drug as an antidepressant. It is unclear at this time how many patients may have had worsening conditions due to the drug’s ineffectiveness. It is unknown how many people may have harmed themselves or others due to the ineffectiveness of the drug.

Consumers trust that generic drugs are equivalent to the brand name version and that the FDA has tested these drugs before approval. This series of events highlights issues with the generic drug approval process and potential harmful effects to consumers.

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