FDA — authorised 29 April 2016
- Marketing authorisation holder: ACADIA PHARMACEUTICALS INC
- Status: approved
🇺🇸 Nuplazid in United States
FDA authorised Nuplazid on 29 April 2016
Marketing authorisations
FDA — authorised 17 October 2017
- Application: NDA207318
- Marketing authorisation holder: ACADIA PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 28 June 2018
- Application: NDA210793
- Marketing authorisation holder: ACADIA PHARMS INC
- Local brand name: NUPLAZID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 January 2024
- Application: ANDA214502
- Marketing authorisation holder: ZYDUS
- Local brand name: PIMAVANSERIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 2024
- Application: ANDA214925
- Marketing authorisation holder: MSN
- Local brand name: PIMAVANSERIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 January 2024
- Application: ANDA214493
- Marketing authorisation holder: ZYDUS
- Local brand name: PIMAVANSERIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA214750
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PIMAVANSERIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA214782
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: PIMAVANSERIN
- Indication: CAPSULE — ORAL
- Status: approved
Nuplazid 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 Nuplazid approved in United States?
Yes. FDA authorised it on 29 April 2016; FDA authorised it on 17 October 2017; FDA authorised it on 28 June 2018.
Who is the marketing authorisation holder for Nuplazid in United States?
ACADIA PHARMACEUTICALS INC holds the US marketing authorisation.