FDA — authorised 24 April 2008
- Application: NDA021964
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: RELISTOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Methylnaltrexone (MNTX) in United States
FDA authorised Methylnaltrexone (MNTX) on 24 April 2008
Marketing authorisations
FDA — authorised 19 July 2016
- Application: NDA208271
- Marketing authorisation holder: SALIX
- Local brand name: RELISTOR
- Indication: TABLET — ORAL
- Status: approved
Methylnaltrexone (MNTX) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Methylnaltrexone (MNTX) approved in United States?
Yes. FDA authorised it on 24 April 2008; FDA authorised it on 19 July 2016.
Who is the marketing authorisation holder for Methylnaltrexone (MNTX) in United States?
SALIX PHARMS holds the US marketing authorisation.