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Introduction: Comparison of the Bioequivalence of Generic Versus Branded Clozapine

Larry Ereshefsky, PharmD; Marvin C. Meyer, PhD

Published: April 1, 2001

Article Abstract

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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.

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