FDA — authorised 5 May 2017
- Application: NDA209176
- Marketing authorisation holder: SHIONOGI
- Local brand name: RADICAVA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Radicava in United States
FDA authorised Radicava on 5 May 2017
Marketing authorisations
FDA — authorised 12 May 2022
- Application: NDA215446
- Marketing authorisation holder: KK BCJ-94
- Status: approved
FDA
- Status: approved
Radicava in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Radicava approved in United States?
Yes. FDA authorised it on 5 May 2017; FDA authorised it on 12 May 2022; FDA has authorised it.
Who is the marketing authorisation holder for Radicava in United States?
SHIONOGI holds the US marketing authorisation.