FDA — authorised 31 January 2006
- Marketing authorisation holder: SUCAMPO PHARMA LLC
- Status: approved
🇺🇸 Amitiza in United States
FDA authorised Amitiza on 31 January 2006
Marketing authorisations
FDA — authorised 31 January 2006
- Application: NDA021908
- Marketing authorisation holder: SUCAMPO PHARMA LLC
- Local brand name: AMITIZA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 November 2021
- Application: ANDA209450
- Marketing authorisation holder: AMNEAL
- Local brand name: LUBIPROSTONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 March 2023
- Application: ANDA214131
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LUBIPROSTONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 January 2025
- Application: ANDA218640
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: LUBIPROSTONE
- Indication: CAPSULE — ORAL
- Status: approved
Amitiza 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 Amitiza approved in United States?
Yes. FDA authorised it on 31 January 2006; FDA authorised it on 31 January 2006; FDA authorised it on 30 November 2021.
Who is the marketing authorisation holder for Amitiza in United States?
SUCAMPO PHARMA LLC holds the US marketing authorisation.