FDA — authorised 17 April 2024
- Application: NDA214511
- Marketing authorisation holder: LUMICELL
- Local brand name: LUMISIGHT
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA authorised Pegulicianine on 17 April 2024
Yes. FDA authorised it on 17 April 2024; FDA has authorised it.
LUMICELL holds the US marketing authorisation.