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: 55.87). 12/2012; 367(26). DOI: 10.1056/NEJMp1212969
Source: PubMed


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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    • "Niemniej jednak, produkt ten podlega porejestracyjnemu monitorowaniu bezpieczeństwa i skuteczności. Dowodem na zasadność takiego działania jest przypadek porejestracyjnego wycofania z rynku USA jednego z produktów generycznych zawierających bupropion [11]. Dotychczas opublikowano kilka przeglądów literatury podsumowujących przypadki zamiennego stosowania przeciwdepresyjnych i przeciwpsychotycznych produktów referencyjnych i generycznych. "
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    ABSTRACT: It is the objective of this paper to discuss the requirements that must be met by generic drugs and explain basic concepts relating to bioequivalence. The authors have also included two tables listing the trading names of antidepressants and antipsychotics, with a valid authorization for marketing in Poland, which might prove helpful in daily psychiatric practice.
    Postepy Psychiatrii i Neurologii 02/2015; 30(1). DOI:10.1016/
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    • "In agreement with this statement, a recent paper published in the New England Journal of Medicine by members of the US Food and Drug Administration shows that budeprion, the generic version of bupropion, was bioequivalent to the branded drug at the dosage of 150 mg, but not at the dosage of 300 mg, in fact suggesting that bioequivalence at different dosages should be demonstrated by clinical studies and not extrapolated [36]. "
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    Advances in Therapy 07/2014; 31(7). DOI:10.1007/s12325-014-0130-z · 2.27 Impact Factor
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    • "In the past, the FDA has initiated product quality evaluations of the FDA-approved drugs (e.g. budeprion, heparin and vancomycin) [20] [21] [22] [23] [24] in response to concerns about their quality. In this work, because of concerns with switching tacrolimus drug sources during the often long period of anti-organ rejection treatment, the agency has performed analytical testing and in vitro bioassay comparison studies of the innovator and generic tacrolimus products available in the US marketplace. "
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    ABSTRACT: Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentration/dose ratio in the plasma of liver and kidney recipients when the reference listed drug was substituted with a generic drug. In response to these concerns about switching between tacrolimus from different approved manufacturers during treatment, the FDA initiated purity, potency and quality studies of the innovator and generic tacrolimus products available in the US marketplace. A combination of analytical methods, including mass spectrometry (LC-MS), nuclear magnetic resonance (NMR) and bioactivity assay were developed and validated to assess the quality of tacrolimus. These tests measured the identity, impurities and activity of tacrolimus from active pharmaceutical ingredient (API) sources and with formulated drug product from five different approved manufactures. In addition, some testing was performed on tacrolimus capsules obtained from a non US approved Indian source. The data obtained showed no discernible difference in the impurity profiles and potency between the generic and innovator tacrolimus products.
    Journal of pharmaceutical and biomedical analysis 07/2013; 85C:108-117. DOI:10.1016/j.jpba.2013.07.001 · 2.98 Impact Factor
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