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The FDA approved Pfizer's extended-spectrum antifungal voriconazole (Vfend) for the treatment of candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds. The approval was for the intravenous, tablets, and oral suspension formulations of voriconazole.

 

According to Pfizer, voriconazole is effective against Candida species that include hard-to-treat pathogens such as C. glabrata and C. krusei.

 

The approval was based on the results of a multicenter study of 422 patients randomized to receive either voriconazole or amphotericin B followed by fluconazole. At the end of weeks 2, 6, and 12 of treatment, clinical response was assessed. Voriconazole was as effective as a regimen of amphotericin B followed by fluconazole and was able to clear Candida from the blood as quickly as amphotericin B with lower incidence of treatment-related adverse events.

 

The most common side effects during the study were sepsis, fever, hypokalemia, hypotension, and respiratory disorder.