FDA — authorised 24 April 2008
- Marketing authorisation holder: SALIX PHARMS
- Status: approved
🇺🇸 Relistor in United States
FDA authorised Relistor on 24 April 2008
Marketing authorisations
FDA — authorised 19 July 2016
- Application: NDA208271
- Marketing authorisation holder: SALIX
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 14 March 2018
- Application: NDA021964
- Marketing authorisation holder: SALIX PHARMS
- Indication: Labeling
- Status: approved
Relistor 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 Relistor approved in United States?
Yes. FDA authorised it on 24 April 2008; FDA authorised it on 19 July 2016; FDA authorised it on 14 March 2018.
Who is the marketing authorisation holder for Relistor in United States?
SALIX PHARMS holds the US marketing authorisation.