FDA — authorised 8 October 2019
- Application: NDA210797
- Marketing authorisation holder: CLIVUNEL INC
- Local brand name: SCENESSE
- Indication: IMPLANT — SUBCUTANEOUS
- Status: approved
🇺🇸 Scenesse in United States
FDA authorised Scenesse on 8 October 2019
Marketing authorisation
Scenesse in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Scenesse approved in United States?
Yes. FDA authorised it on 8 October 2019.
Who is the marketing authorisation holder for Scenesse in United States?
CLIVUNEL INC holds the US marketing authorisation.