Posted by Michael Wonder on 10 Aug 2023
US FDA accepts Astellas' sNDA for Cresemba (isavuconazonium sulphate) in children
10 August 2023 - Astellas announced that the US FDA has accepted the company's supplemental new drug application for Cresemba (isavuconazonium sulphate), a prodrug of isavuconazole, an azole anti-fungal drug, seeking approval for the treatment of invasive aspergillosis or invasive mucormycosis in paediatric patients aged one to 17 years old.
Under the Prescription Drug User Fee Act, the FDA has set a target action date of 9 December 2023.
