FDA — authorised 21 December 2015
- Marketing authorisation holder: ACTELION PHARMS LTD
- Status: approved
🇺🇸 Uptravi in United States
FDA authorised Uptravi on 21 December 2015
Marketing authorisations
FDA — authorised 21 December 2015
- Application: NDA207947
- Marketing authorisation holder: ACTELION
- Local brand name: UPTRAVI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2022
- Application: ANDA214302
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: SELEXIPAG
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 2023
- Application: ANDA214414
- Marketing authorisation holder: ALEMBIC
- Local brand name: SELEXIPAG
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2026
- Application: ANDA214055
- Marketing authorisation holder: RK PHARMA
- Local brand name: SELEXIPAG
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214367
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: SELEXIPAG
- Indication: TABLET — ORAL
- Status: approved
Uptravi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Uptravi approved in United States?
Yes. FDA authorised it on 21 December 2015; FDA authorised it on 21 December 2015; FDA authorised it on 21 December 2022.
Who is the marketing authorisation holder for Uptravi in United States?
ACTELION PHARMS LTD holds the US marketing authorisation.