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Cymbalta Pregnancy Risk Fit FDA's New Power To Mandate Post-Market Study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's application of its new ability to require - as opposed to request - post-marketing studies under the FDA Amendments Act is on display in the review of a fibromyalgia claim for Lilly's Cymbalta (duloxetine)

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Telavancin’s “Complete Response” Letter Calls For Pregnancy-Focused REMS

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Chart: Current Class Of Risk Evaluation & Mitigation Strategires

The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months

FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on roughly one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March.

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