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.