FDA — authorised 12 August 2024
- Application: BLA761390
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: NEMLUVIO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised CD14152 Dose A on 12 August 2024
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 August 2024.
GALDERMA LABS LP holds the US marketing authorisation.