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Noxafil Approved for Treatment of Oropharyngeal Candidiasis

Noxafil Approved for Treatment of Oropharyngeal Candidiasis

ROCKVILLE, Maryland--The FDA has approved Schering-Plough's novel triazole antifungal agent Noxafil (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole. The drug recently received FDA approval for the 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 cell transplant recipients with graft-vs-host disease or those with hematological malignancies with prolonged neutropenia from chemotherapy (see ONI October 2006, page 1).

The FDA approval of Noxafil for treating oropharyngeal candidiasis is based primarily on the results of a randomized, controlled, evaluator-blinded clinical study in HIV-infected patients that compared Noxafil with fluconazole, as well as a noncomparative study of Noxafil in HIV-infected patients with oropharyngeal candidiasis refractory to treatment with fluconazole or itraconazole.

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