FDA — authorised 8 October 2013
- Application: NDA204819
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: ADEMPAS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Adempas in United States
FDA authorised Adempas on 8 October 2013
Marketing authorisations
FDA — authorised 1 September 2022
- Application: ANDA211135
- Marketing authorisation holder: MSN
- Local brand name: RIOCIGUAT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA211044
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: RIOCIGUAT
- Indication: TABLET — ORAL
- Status: approved
Adempas 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 Adempas approved in United States?
Yes. FDA authorised it on 8 October 2013; FDA authorised it on 1 September 2022; FDA has authorised it.
Who is the marketing authorisation holder for Adempas in United States?
BAYER HLTHCARE holds the US marketing authorisation.