FDA — authorised 5 June 2017
- Application: NDA207533
- Marketing authorisation holder: ALKERMES INC
- Indication: Efficacy
- Status: approved
🇺🇸 Aristada in United States
FDA authorised Aristada on 5 June 2017
Marketing authorisations
FDA — authorised 29 June 2018
- Application: NDA209830
- Marketing authorisation holder: ALKERMES INC
- Local brand name: ARISTADA INITIO KIT
- Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
Aristada, a medication developed by Alkermes Inc, has been granted marketing authorization by the US FDA. This authorization was issued on January 22, 2025, following a standard expedited pathway. The approved labeling for Aristada indicates its intended use, but further details are not specified.
Aristada 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 Aristada approved in United States?
Yes. FDA authorised it on 5 June 2017; FDA authorised it on 29 June 2018.
Who is the marketing authorisation holder for Aristada in United States?
ALKERMES INC holds the US marketing authorisation.