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FUJISAWA AMBISOME COULD BE FIRST EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTION; FUTURE TRIALS SHOULD DEFINE PRESUMED INFECTIONS, FDA COMMITTEE SAYS

Executive Summary

Fujisawa USA's Ambisome could be the first approved empirical therapy in febrile neutropenic patients, following a unanimous vote by FDA's Antiviral Drugs Advisory committee July 16 that the liposomal amphotericin B product is safe and effective for the indication. Fujisawa USA licenses the product from Boulder, Colo.-based NeXstar Pharmaceuticals.
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