FDA Revokes Approval of 300 mg Generic Bupropion

The Food and Drug Administration (FDA) announced last week that it has withdrawn its approval for a generic version of the antidepressant bupropion manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals USA. It asked the companies to remove it from the market, and they complied voluntarily.

The FDA action on the 300 mg—but not the 150 mg—strength of the product, which is marketed as Budeprion XL (extended relief) comes about five years after the FDA started receiving reports "that patients who were switched from Wellbutrin XL 300 to its generic counterparts were experiencing reduced efficacy." The FDA decided in 2010 to conduct tests on the product after dozens of complaints were received over several years about relapses and side effects after patients switched to a generic version. Its tests showed that "Budeprion XL 300 is not absorbed into the bloodstream at the same rate and to the same extent as Wellbutrin XL 300 mg." As for the multiyear delay in conducting tests on Budeprion, the FDA acknowledged that "A less-cautious approach in studying the bioequivalence of Budeprion XL 300 mg could have brought the data to light earlier."

The agency advised that "Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health care professionals if they have questions about taking this medication." The FDA pointed out that it has no data "showing that the other four generic [bupropion] products are not bioequivalent to Wellbutrin XL 300 mg."

To read about data on comparative efficacy of bupropion and other antidepressants, see Psychiatric News.

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