FDA — authorised 3 February 2023
- Application: ANDA213718
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
🇺🇸 Rexulti in United States
FDA authorised Rexulti on 3 February 2023
Marketing authorisations
FDA — authorised 7 May 2024
- Application: NDA205422
- Marketing authorisation holder: OTSUKA
- Indication: Efficacy
- Status: approved
The FDA approved Rexulti, a medication developed by OTSUKA, on 7 May 2024. The approval was granted under the standard expedited pathway. The approved indication for Rexulti is based on its demonstrated efficacy.
Rexulti 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 Rexulti approved in United States?
Yes. FDA authorised it on 3 February 2023; FDA authorised it on 7 May 2024.
Who is the marketing authorisation holder for Rexulti in United States?
AJANTA PHARMA LTD holds the US marketing authorisation.