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Statistics Bedeviled But Did Not Derail Cymbalta Fibromyalgia Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly ran into one review issue with its fibromyalgia NDA for Cymbalta (duloxetine) because it did not adhere to a "well established policy" of the FDA division responsible for analgesic drugs regarding imputation of missing data, a recurring statistical issue in pain drug reviews, review documents show

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