FDA — authorised 7 October 2025
- Application: NDA217294
- Marketing authorisation holder: SQ INNOVATION
- Local brand name: LASIX ONYU
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA authorised Lasix ONYU on 7 October 2025
Yes. FDA authorised it on 7 October 2025.
SQ INNOVATION holds the US marketing authorisation.