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Basilea Pharmaceutica AG announces isavuconazole received QIDP designation from U.S. FDA


Wednesday, 16 Jul 2014 12:11pm EDT 

Basilea Pharmaceutica AG:Says that U.S. Food and Drug Administration (FDA) designated isavuconazole as Qualified Infectious Disease Product (QIDP) for oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts.QIDP designation, granted under U.S. GAIN Act, provides priority review and five-year extension of market exclusivity, should product be approved in United States.Isavuconazole was previously granted QIDP designation for treatment of invasive aspergillosis and invasive mucormycosis which are severe mold infections.In addition, isavuconazole FDA fast-track status and received U.S. and European Union orphan drug designations for invasive aspergillosis and mucormycosis.