Budeprion XL 300 mg, one of the generic formulations of the extended-release bupropion hydrochloride (brand-name Wellbutrin XL 300 mg) antidepressant, has been removed from the market at the US Food and Drug Administration (FDA) request.
There are 5 generic versions of Wellbutrin XL 300 mg, which were approved based on the bioequivalence studies performed with the 150 mg strength and extrapolated to the 300 mg products, according to FDA´s guidance.
Budeprion XL 300 mg, manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., was approved in December 2006. Patients receiving these tablets reported reduced efficacy and the FDA asked Impax/Teva to perform a bioequivalence study comparing to Wellbutrin XL 300 mg, and including such patients. Due to inability to include enough patients, the FDA sponsored the study with 24 healthy volunteers and recently showed that Budeprion XL 300 mg tablets did not release bupropion into the blood at the same extent as Wellbutrin XL 300 mg.
FDA has asked the other generics manufacturers to conduct studies to assess the bioequivalence of their 300 mg extended-release bupropion tablets to Wellbutrin XL 300 mg, although there are no indications that such generics are not bioequivalent.