US FDA clears S-P's Noxafil for expanded indication

US drug major Schering-Plough says that the Food and Drug Administration has approved Noxafil (posaconazole) oral suspension for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida and Noxafil is a novel triazole antifungal agent originated by S-P.

This move follows the FDA's September 15 approval of the agent for prevention of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host-disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Invasive fungal infections are a leading cause of death in these high-risk populations, S-P noted.