FDA — authorised 24 June 2025
- Application: ANDA219078
- Marketing authorisation holder: SOMERSET THERAP
- Status: approved
🇺🇸 PRUCALOPRIDE in United States
FDA authorised PRUCALOPRIDE on 24 June 2025
Marketing authorisations
FDA — authorised 24 June 2025
- Application: ANDA219160
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 24 June 2025
- Application: ANDA217662
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 24 June 2025
- Application: ANDA219193
- Marketing authorisation holder: SPECGX LLC
- Status: approved
FDA — authorised 7 August 2025
- Application: ANDA218056
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA
- Status: approved
PRUCALOPRIDE 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 PRUCALOPRIDE approved in United States?
Yes. FDA authorised it on 24 June 2025; FDA authorised it on 24 June 2025; FDA authorised it on 24 June 2025.
Who is the marketing authorisation holder for PRUCALOPRIDE in United States?
SOMERSET THERAP holds the US marketing authorisation.