Treats hallucinations and delusions associated with Parkinson's disease psychosis. NDA 210793, held by Acadia Pharms Inc. Pimavanserin Tartrate.
As of Nov 13, 2026, NDA 210793 (Nuplazid), held by Acadia Pharms Inc, was first approved by FDA on Jun 28, 2018, with 7 approved supplements and 0 published complete response letters.
NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
| Apr 27, 2026 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jun 28, 2018 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| NuplazidEQ 34MG BASE · capsule;oral | Pimavanserin Tartrate | RxReference drug |
| Apr 27, 2026 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Jan 22, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Sep 15, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Sep 27, 2019 | Supplement 3Labeling · Standard review | Approved | |
| May 10, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Mar 4, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Jun 28, 2018 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
