FDA Approves Schering-Plough Fungal Treatment
Posted on: Tuesday, 24 October 2006, 15:01 CDT
Schering-Plough Corporation has reported that the FDA has approved Noxafil for a fungal infection of the mouth and throat which is caused by yeast.
Noxafil is an antifungal agent discovered and developed by Schering-Plough Research Institute to treat this fungal infection also known as oropharyngeal candidiasis (OPC).
This follows the FDA approval of Noxafil in September for prevention of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to a lowered immune system. Invasive fungal infections are a leading cause of death in these high-risk populations.
The European Medicines Agency issued a positive opinion on September 21 recommending approval of Noxafil for the prophylaxis indication and for first-line treatment of OPC. These applications are currently pending a final European Commission decision. Noxafil is currently approved in the EU and Australia for the treatment of certain invasive fungal infections in adult patients.
The FDA approval of Noxafil for treating OPC is based primarily on the results of a clinical study in HIV-infected patients.
Source: Datamonitor
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