FDA — authorised 7 January 2022
- Application: NDA214985
- Marketing authorisation holder: IDORSIA
- Local brand name: QUVIVIQ
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Daridorexant 50 mg in United States
FDA authorised Daridorexant 50 mg on 7 January 2022
Marketing authorisations
FDA
- Status: approved
Daridorexant 50 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Daridorexant 50 mg approved in United States?
Yes. FDA authorised it on 7 January 2022; FDA has authorised it.
Who is the marketing authorisation holder for Daridorexant 50 mg in United States?
IDORSIA holds the US marketing authorisation.