FDA — authorised 17 December 1999
- Application: NDA021038
- Marketing authorisation holder: HOSPIRA
- Local brand name: PRECEDEX
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Precedex in United States
FDA authorised Precedex on 17 December 1999
Marketing authorisations
FDA — authorised 27 August 2020
- Application: ANDA212571
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 25 March 2021
- Application: ANDA204843
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA201072
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA218112
- Marketing authorisation holder: SOMERSET
- Status: approved
FDA — authorised 19 November 2025
- Application: NDA215390
- Marketing authorisation holder: BIOXCEL
- Indication: Efficacy
- Status: approved
The FDA approved Precedex, a medication developed by BIOXCEL, for its approved indication on 19 November 2025. The application number for this approval is NDA215390. This approval was granted through the standard expedited pathway.
Precedex 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 Precedex approved in United States?
Yes. FDA authorised it on 17 December 1999; FDA authorised it on 27 August 2020; FDA authorised it on 25 March 2021.
Who is the marketing authorisation holder for Precedex in United States?
HOSPIRA holds the US marketing authorisation.