Article

Withdrawal of Generic Budeprion for Nonbioequivalence

From the Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD.
New England Journal of Medicine (Impact Factor: 54.42). 12/2012; 367(26). DOI: 10.1056/NEJMp1212969
Source: PubMed

ABSTRACT 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 . . .

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