FDA — authorised 22 June 2015
- Application: NDA204958
- Marketing authorisation holder: CHIESI
- Local brand name: KENGREAL
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA authorised Kengreal on 22 June 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 June 2015; FDA authorised it on 11 August 2025.
CHIESI holds the US marketing authorisation.