FDA — authorised 28 July 1983
- Status: approved
🇺🇸 Chenix in United States
FDA authorised Chenix on 28 July 1983
Marketing authorisations
FDA — authorised 28 July 1983
- Application: NDA018513
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Local brand name: CHENIX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2009
- Application: ANDA091019
- Marketing authorisation holder: LGM PHARMA
- Status: approved
FDA — authorised 21 February 2025
- Application: NDA219488
- Marketing authorisation holder: MIRUM
- Local brand name: CTEXLI
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Chenix, a new formulation or new manufacturer, on 2025-02-21. The marketing authorisation holder is MIRUM. Chenix was approved under the standard expedited pathway.
Chenix 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 Chenix approved in United States?
Yes. FDA authorised it on 28 July 1983; FDA authorised it on 28 July 1983; FDA authorised it on 22 October 2009.
Who is the marketing authorisation holder for Chenix in United States?
Marketing authorisation holder not available in our data.