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Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several generic prograf price transplant societies and publications have generated skepticism of the generic approval process. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed.
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Novartis Expands Transplant Portfolio With First Branded Generic Tacrolimus
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Tacrolimus is a cornerstone of immunosuppressive treatment after solid organ transplantation. All patients were instructed to take tacrolimus doses at specified times to ensure accurate determination of trough blood concentrations.
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