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Abilify Comparative Safety Claims Require Least Favorable Dose Comparison

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Comparative safety claims for Bristol-Myers Squibb/Otsuka’s atypical antipsychotic Abilify would require studies comparing the highest dose of aripiprazole to the lowest dose of the comparator or a more complicated multi-dose comparative trial, FDA review documents show.

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