FDA — authorised 30 March 2016
- Marketing authorisation holder: GENTIUM SRL
- Status: approved
🇺🇸 Defitelio in United States
FDA authorised Defitelio on 30 March 2016
Marketing authorisations
FDA — authorised 30 March 2016
- Application: NDA208114
- Marketing authorisation holder: JAZZ PHARMS INC
- Local brand name: DEFITELIO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Defitelio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Defitelio approved in United States?
Yes. FDA authorised it on 30 March 2016; FDA authorised it on 30 March 2016.
Who is the marketing authorisation holder for Defitelio in United States?
GENTIUM SRL holds the US marketing authorisation.