FDA — authorised 4 April 2024
- Application: NDA216593
- Marketing authorisation holder: NOVA LABS LTD
- Local brand name: XROMI
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Xromi in United States
FDA authorised Xromi on 4 April 2024
Marketing authorisations
FDA
- Status: approved
Xromi 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 Xromi approved in United States?
Yes. FDA authorised it on 4 April 2024; FDA has authorised it.
Who is the marketing authorisation holder for Xromi in United States?
NOVA LABS LTD holds the US marketing authorisation.