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Case Report: A Case of Akathisia After Switching From Branded to Generic High-Dose Olanzapine
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As many established atypical antipsychotics lose patent exclusivity, use of generic atypical antipsychotics will expectably rise in light of cost. US Food and Drug Administration (FDA) approval of generic drugs requires demonstration of bioequivalence of a generic agent (specifically, a plasma C and area under the curve [AUC] falling within a 90% confidence interval of 80%–125% of that achieved with a branded formulation) but no required evaluation of efficacy or tolerability. Limited data make it difficult for clinicians to advise patients on when less-expensive generic formulations differ from branded drugs in efficacy or adverse effects.
The FDA approved the first generic formulation of olanzapine on October 24, 2011.