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No Comparison: Viibryd’s Path Of Least Resistance Through FDA Could Mean Rocky Marketing

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s statutory neutrality on comparative effectiveness in drug approval decisions both helped and held back Viibryd (vilazodone), now owned by Forest Laboratories. Because approval requires only that a candidate proves superiority to placebo, not to any existing treatments, the antidepressant entered a highly competitive, crowded market with statistically significant but commercially unremarkable efficacy.

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