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GSK Alli Review Contrasts OTC, Rx Division Perspectives On Obesity Drugs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

OTC suitability of alli (orlistat) was questioned by primary clinical reviewer from FDA's Division of Metabolism & Endocrinology Products. Both Metabolism & Endocrinology and Nonprescription Divisions found GSK's NDA for an Rx-to-OTC switch of orlistat initially "approvable," but with markedly different proposals for remediation. OTC division looked for better labeling, but was satisfied with efficacy. DMEP focused on maximizing safety/efficacy ratio and called for an actual use study that tested corollary educational measures, but the proposal was rejected at the office level because it would test effectiveness, not efficacy, invoking a standard that was not applied to orlistat in the Rx setting. Regulatory requirements should be consistent, ODE II Director Rosebraugh says

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