FDA — authorised 12 August 2020
- Marketing authorisation holder: NIPPON SHINYAKU
- Status: approved
🇺🇸 Viltepso in United States
FDA authorised Viltepso on 12 August 2020
Marketing authorisations
FDA — authorised 12 August 2020
- Application: NDA212154
- Marketing authorisation holder: NIPPON SHINYAKU
- Local brand name: VILTEPSO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Viltepso 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 Viltepso approved in United States?
Yes. FDA authorised it on 12 August 2020; FDA authorised it on 12 August 2020.
Who is the marketing authorisation holder for Viltepso in United States?
NIPPON SHINYAKU holds the US marketing authorisation.