Vilazodone: Clinical Basis for the US Food and Drug Administration's Approval of a New Antidepressant.

The article examines the decision of the U.S. Food and Drug Administration (FDA) to approve the drug vilazodone for major depressive disorder (MDD). Particular focus is given to the approach by FDA to its review of the clinical pharmacology and clinical efficacy and safety data for the drug. The pharmacokinetics and dose-response characterization of vilazodone are tackled. The similarity of the drug's adverse events with other selective serotonin reuptake inhibitors (SSRIs) is explained.