Withdrawal of Generic Budeprion for Nonbioequivalence

The FDA has found, in its own direct comparison, that generic Budeprion XL 300 mg is not therapeutically equivalent to brand-name Wellbutrin XL 300 mg. The agency is therefore changing its bioequivalence recommendations for extended-release bupropion products. The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies. Within a year after gaining approval at the end . . .