Panel backs Optimer's intestinal infection drug, but hesitant on recurrence data
This article was originally published in Scrip
Executive Summary
A federal panel of advisers for the US FDA 5 April unanimously backed the safety and effectiveness of Optimer Pharmaceuticals experimental oral antibiotic Dificid (fidaxomicin) in treating Clostridium difficile infection (CDI), a disease that can cause serious diarrhea and other intestinal conditions, such as colitis, sometimes resulting in death.