isavuconazonium as sulfate
Isavuconazole (BAL4815) is a triazole antifungal. Its prodrug, Isavuconazonium sulfate (BAL8557) is currently in Phase III clinical trials.
Basilea reports isavuconazole orphan drug designation by US FDA
ITNews
Pharmaceutica AG / Basilea reports isavuconazole orphan drug designation by U.S. FDA .
Basel, Switzerland, May 28, 2013 – Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis. An FDA orphan drug designation provides several benefits to the sponsor including a seven-year market exclusivity from product approval in the U.S. Isavuconazole was previously granted FDA fast track status that is designed to facilitate development and expedite the review of drugs to treat serious diseases
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational intravenous and oral broad-spectrum antifungal.
In collaboration with Astellas Pharma Inc., isavuconazole is being investigated in phase 3 clinical … read all at
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