Introduction: Comparison of the Bioequivalence of Generic Versus Branded Clozapine

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Clozapine, the first atypical antipsychotic, has been marketed as Clozaril for patients with treatment-refractory schizophrenia since 1989. The patent for Clozaril expired in 1998, and 3 generic formulations of clozapine have received U.S. Food and Drug Administration (FDA) approval. The FDA considers Clozaril (Novartis Pharmaceuticals Corporation) and the 3 generic forms of clozapine manufactured by Zenith Goldline Pharmaceuticals, Mylan Pharmaceutical, and Geneva Pharmaceuticals, which is a subsidiary of Novartis, to be therapeutically equivalent.


J Clin Psychiatry 2001;62(suppl 5):3-3

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