FDA — authorised 14 August 2019
- Marketing authorisation holder: HARMONY
- Status: approved
🇺🇸 Wakix in United States
FDA authorised Wakix on 14 August 2019
Marketing authorisations
FDA — authorised 14 August 2019
- Application: NDA211150
- Marketing authorisation holder: HARMONY
- Local brand name: WAKIX
- Indication: TABLET — ORAL
- Status: approved
Wakix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Wakix approved in United States?
Yes. FDA authorised it on 14 August 2019; FDA authorised it on 14 August 2019.
Who is the marketing authorisation holder for Wakix in United States?
HARMONY holds the US marketing authorisation.