FDA — authorised 21 May 2002
- Marketing authorisation holder: UNITED THERAP
- Status: approved
🇺🇸 Remodulin in United States
FDA authorised Remodulin on 21 May 2002
Marketing authorisations
FDA — authorised 24 November 2004
- Application: NDA021272
- Marketing authorisation holder: UNITED THERAP
- Indication: Efficacy
- Status: approved
FDA — authorised 19 October 2017
- Application: NDA022387
- Marketing authorisation holder: UNITED THERAP
- Indication: Efficacy
- Status: approved
FDA — authorised 22 May 2020
- Application: ANDA210214
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA211574
- Marketing authorisation holder: ALEMBIC GLOBAL
- Status: approved
FDA — authorised 23 May 2025
- Application: NDA213005
- Marketing authorisation holder: LIQUIDIA TECH
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Remodulin, a drug for a new formulation or new manufacturer, on 2025-05-23. This approval was granted to LIQUIDIA TECH under NDA213005. The approval was made through the standard expedited pathway.
Remodulin 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 Remodulin approved in United States?
Yes. FDA authorised it on 21 May 2002; FDA authorised it on 24 November 2004; FDA authorised it on 19 October 2017.
Who is the marketing authorisation holder for Remodulin in United States?
UNITED THERAP holds the US marketing authorisation.