FDA — authorised 5 May 2017
- Marketing authorisation holder: MITSUBISHI TANABE PHARMA DEVELOPMENT AMERICA INC
- 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: SHIONOGI
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 18 November 2022
- Application: NDA209176
- Marketing authorisation holder: SHIONOGI
- Indication: Labeling
- Status: approved
FDA — authorised 6 May 2024
- Application: ANDA216199
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA217565
- Marketing authorisation holder: PHARMOBEDIENT
- Status: approved
FDA — authorised 23 December 2024
- Application: ANDA216902
- Marketing authorisation holder: SANDOZ
- 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 authorised it on 18 November 2022.
Who is the marketing authorisation holder for Radicava in United States?
MITSUBISHI TANABE PHARMA DEVELOPMENT AMERICA INC holds the US marketing authorisation.