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Basilea Pharmaceutica AG announces isavuconazole received QIDP designation from U.S. FDA
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.
Latest Developments for Basilea Pharmaceutica AG
- Basilea Pharmaceutica AG receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis
- Basilea Pharmaceutica AG confirms FY 2014 guidance
- Basilea Pharmaceutica AG submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections
- Basilea Pharmaceutica AG Isavuconazole receives orphan drug designations in Europe
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