FDA — authorised 19 December 1997
- Application: NDA020686
- Marketing authorisation holder: BRACCO
- Local brand name: LUMENHANCE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA authorised LUMENHANCE on 19 December 1997
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 19 December 1997; FDA has authorised it.
BRACCO holds the US marketing authorisation.