FDA Relents, Approves Novel Antidepressant After Many Rejections
After multiple prior rejections, gepirone hydrochloride extended-release (ER; Exxua) gained FDA approval for the treatment of major depressive disorder (MDD) in adults, drugmaker Fabre-Kramer Pharmaceuticals announced. Gepirone ER is the first approved antidepressant that selectively targets the serotonin 1A receptor, which regulates mood and emotion. The drug was approved based on data from two 8-week […]