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.
    Preview · Article · Feb 2015 · Postepy Psychiatrii i Neurologii
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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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    ABSTRACT: Pain presents in 80% of patients with advanced cancer, and 30% have periods of increased pain due to fluctuating intensity, known as breakthrough cancer pain (BTcP). BTcP is high-intensity, short-duration pain occurring in several episodes per day and is non-responsive to treatment. The clinical approach to BTcP is variable. A review of the literature was performed to provide clinicians and practitioners with a rational synthesis of the ongoing scientific debate on BTcP and to provide a basis for optimal clinical approach to BTcP in adult Italian patients. Data show that circadian exacerbations of pain should be carefully monitored, differentiating, if possible, between fluctuations of background pain (BP), end-of-dose effect, and BTcP. BTcP should be monitored in all care contexts in clinical practice and each care facility must have all the medications and products approved for use in BTcP at their disposal. Data show that knowledge about medications for BTcP is lacking: medications for BTcP treatment are not interchangeable, although containing the same active substance; each physician must know the specific characteristics of each medication, its pharmacological properties, limitations in clinical practice, specifics relating to titration and repeatability of administration, and technical specifics relating to the accessibility and delivery. Importantly, before choosing a rapid-onset opioid (ROO), it is essential to deeply understand the status of patient and the characteristics of their family unit/caregivers, taking into account the patient's progressive loss of autonomy and/or cognitive-relational functionality. When BTcP therapy is initiated or changed, special attention must be paid to training the patient and family members/caregivers, providing clear instructions regarding the timing of drug administration. The patient must already be treated effectively with opioids before introducing ROOs for control of BTcP.
    Preview · Article · Jul 2014 · Advances in Therapy
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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.
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