CPhI Online

Pipeline - Isavuconazole Product Profile

18 Sep 2020

Isavuconazole 200mg Powder for concentrate for solution for infusion
Reference Product: Cresemba® / Basilea Pharmaceutica (Pfizer)

Description: Isavuconazole is an antifungal agent which is indicated in adults for the treatment of:
• invasive aspergillosis
• mucormycosis in patients for whom amphotericin B is inappropriate
Dossier Status: On-going
Stability Studies: 2-8 oC (Long Term) & 25 oC/60% RH (accelerated)
Shelf life (Originator): Four (4) years
Batch Sizes: To be defined
Pack Sizes: To be defined / Originator pack: BT x 1 vial (10 ml)