FDA — authorised 12 September 2019
- Application: NDA211801
- Marketing authorisation holder: ARDELYX INC
- Local brand name: IBSRELA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ibsrela in United States
FDA authorised Ibsrela on 12 September 2019
Marketing authorisations
FDA
- Status: approved
Ibsrela 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 Ibsrela approved in United States?
Yes. FDA authorised it on 12 September 2019; FDA has authorised it.
Who is the marketing authorisation holder for Ibsrela in United States?
ARDELYX INC holds the US marketing authorisation.