FDA — authorised 10 March 2023
- Marketing authorisation holder: ACADIA PHARMS INC
- Status: approved
🇺🇸 Daybue in United States
FDA authorised Daybue on 10 March 2023
Marketing authorisations
FDA — authorised 10 March 2023
- Application: NDA217026
- Marketing authorisation holder: ACADIA PHARMS INC
- Local brand name: DAYBUE
- Indication: SOLUTION — ORAL
- Status: approved
The FDA approved Daybue, a drug developed by ACADIA PHARMS INC, for a specific indication. The approval was granted through a standard expedited pathway. Daybue is now available for use in the United States.
FDA — authorised 11 December 2025
- Application: NDA219884
- Marketing authorisation holder: ACADIA PHARMS INC
- Local brand name: DAYBUE STIX
- Indication: SOLUTION — ORAL
- Status: approved
The FDA approved Daybue, a new dosage form, on 11 December 2025. The marketing authorisation holder is ACADIA PHARMS INC. Daybue was approved under the standard expedited pathway. The indication approved is Type 3, which refers to a new dosage form.
Daybue in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Daybue approved in United States?
Yes. FDA authorised it on 10 March 2023; FDA authorised it on 10 March 2023; FDA authorised it on 11 December 2025.
Who is the marketing authorisation holder for Daybue in United States?
ACADIA PHARMS INC holds the US marketing authorisation.