FDA APPROVES SCHERING'S NOXAFIL

The FDA announced Sept. 18 it has approved Schering-Plough's drug Noxafil, which prevents invasive fungal infections in people with weakened immune systems.

The drug is designed to prevent infection caused by aspergillus and candida in patients with weakened immune systems following bone marrow transplants, as well as in patients in which cancer or chemotherapy have decreased their white-blood-cell count, making it difficult for their bodies to fight infections.

"Most healthy individuals are unaffected by these common fungi. However, individuals with severely weakened or abnormal immune systems may become seriously ill when exposed. These infections are often fatal for this population," CDER Director Steven Galson said in a statement.

Noxafil (posaconazole) is a new molecular entity containing an active substance that has never before been approved for marketing in any form in the U.S., the FDA said.