Astellas announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.
Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed for the treatment of severe invasive and life-threatening fungal infections.
Earlier this year, the FDA had designated isavuconazole as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis and invasive mucormycosis. QIDP designation for the treatment of invasive aspergillosis was granted last year. Also, in 2013, isavuconazole was granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis.
For more information call (877) 829-7942 or visit Astellas.com.