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In Brief: Nexstar/Fujisawa AmBisome

Executive Summary

Nexstar/Fujisawa AmBisome: Liposomal amphotericin B NDA (50-740) for empirical therapy of presumed fungal infection in febrile neutropenic patients will be reviewed by FDA's Antiviral Drugs Advisory Committee July 16. On July 14 and 15, committee will discuss utility of plasma HIV RNA measurement as an endpoint in clinical trials of HIV therapies. The meeting will begin at 8:30 a.m. each day at Armory Place in Silver Spring, Md...

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