US FDA sets 5 June as decision date for Salix's crofelemer
This article was originally published in Scrip
Executive Summary
The US FDA granted Salix Pharmaceuticals a six-month priority review for its new drug application for crofelemer, a first-in-class antisecretory agent, as a treatment to control and relieve symptoms of diarrhoea in patients with HIV/AIDS treated with antiretroviral therapy (ART) and set 5 June as the Prescription Drug User Fee Act action date.