FDA — authorised 21 March 2017
- Marketing authorisation holder: NEWRON PHARMS US INC
- Status: approved
🇺🇸 Xadago in United States
FDA authorised Xadago on 21 March 2017
Marketing authorisations
FDA — authorised 21 March 2017
- Application: NDA207145
- Marketing authorisation holder: MDD US
- Local brand name: XADAGO
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA216020
- Marketing authorisation holder: OPTIMUS PHARMA PRIVATE LTD
- Local brand name: SAFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
Xadago 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 Xadago approved in United States?
Yes. FDA authorised it on 21 March 2017; FDA authorised it on 21 March 2017; FDA has authorised it.
Who is the marketing authorisation holder for Xadago in United States?
NEWRON PHARMS US INC holds the US marketing authorisation.