FDA — authorised 6 March 2015
- Application: NDA207500
- Marketing authorisation holder: ASTELLAS
- Local brand name: CRESEMBA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Isavuconazonium sulfate capsules in United States
FDA authorised Isavuconazonium sulfate capsules on 6 March 2015
Marketing authorisations
FDA — authorised 6 March 2015
- Application: NDA207501
- Marketing authorisation holder: ASTELLAS
- Local brand name: CRESEMBA
- Indication: POWDER — INTRAVENOUS
- Status: approved
Isavuconazonium sulfate capsules in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Isavuconazonium sulfate capsules approved in United States?
Yes. FDA authorised it on 6 March 2015; FDA authorised it on 6 March 2015.
Who is the marketing authorisation holder for Isavuconazonium sulfate capsules in United States?
ASTELLAS holds the US marketing authorisation.