FDA — authorised 21 March 2024
- Application: NDA217865
- Marketing authorisation holder: ITALFARMACO SPA
- Local brand name: DUVYZAT
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 Duvyzat in United States
FDA authorised Duvyzat on 21 March 2024
Marketing authorisations
FDA
- Marketing authorisation holder: ITALFARMACO SPA
- Status: approved
Duvyzat in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Duvyzat approved in United States?
Yes. FDA authorised it on 21 March 2024; FDA has authorised it.
Who is the marketing authorisation holder for Duvyzat in United States?
ITALFARMACO SPA holds the US marketing authorisation.