FDA — authorised 27 May 2015
- Marketing authorisation holder: FURIEX PHARMA INC
- Status: approved
🇺🇸 Viberzi in United States
FDA authorised Viberzi on 27 May 2015
Marketing authorisations
FDA — authorised 17 June 2020
- Application: NDA206940
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 14 March 2025
- Application: ANDA213522
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ELUXADOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213576
- Marketing authorisation holder: MSN PHARMACEUTICALS INC
- Local brand name: ELUXADOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213613
- Marketing authorisation holder: ASCEND LABORATORIES, LTD
- Local brand name: ELUXADOLINE
- Indication: TABLET — ORAL
- Status: approved
Viberzi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Viberzi approved in United States?
Yes. FDA authorised it on 27 May 2015; FDA authorised it on 17 June 2020; FDA authorised it on 14 March 2025.
Who is the marketing authorisation holder for Viberzi in United States?
FURIEX PHARMA INC holds the US marketing authorisation.