Nuplazid

Treats hallucinations and delusions associated with Parkinson's disease psychosis. NDA 207318, held by Acadia Pharms Inc. Pimavanserin Tartrate.

As of Nov 13, 2026, NDA 207318 (Nuplazid), held by Acadia Pharms Inc, was first approved by FDA on Apr 29, 2016, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 29, 2016
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Apr 27, 2026	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 15, 2023	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 28, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 29, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


NuplazidEQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Pimavanserin Tartrate	DiscontinuedReference drug
NuplazidEQ 10MG BASE · tablet;oral	Pimavanserin Tartrate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Apr 27, 2026	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 22, 2025	Supplement 14Labeling · Standard review	Approved	Label Letter
Sep 15, 2023	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 23, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
Sep 27, 2019	Supplement 9Labeling · Standard review	Approved	Label Letter
May 10, 2019	Supplement 7Labeling · Standard review	Approved	Label Letter
Mar 4, 2019	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 28, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 6, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
Mar 4, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Mar 4, 2018	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 17, 2017	Supplement 1Labeling · Standard review	Approved	Label Letter
Apr 29, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 207318
Drugs@FDA: Overview at FDA
Company: ACADIA Pharmaceuticals

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