← FDA DRUG APPROVALS

FDA NDA · NDA207318

NUPLAZID

pimavanserin tartrate

Sponsor: ACADIA PHARMS INC

APPLICATION
NDA207318
TYPE
NDA
ORIGINAL APPROVAL
2016-04-29
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

NUPLAZID · ReferenceDiscontinued
PIMAVANSERIN TARTRATE EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NUPLAZID · ReferencePrescription
PIMAVANSERIN TARTRATE EQ 10MG BASE · TABLET · ORAL

Approval history

2026-04-27Efficacy · Supplement 16 · priority — Letter ↗AP
2025-01-22Labeling · Supplement 14 · standard — Label ↗AP
2023-09-15Efficacy · Supplement 12 · standard — Letter ↗AP
2020-11-23Labeling · Supplement 10 · standard — Label ↗AP
2019-09-27Labeling · Supplement 9 · standard — Letter ↗AP
2019-05-10Labeling · Supplement 7 · standard — Letter ↗AP
2019-03-04Labeling · Supplement 6 · standard — Label ↗AP
2018-06-28Efficacy · Supplement 3 · standard — Letter ↗AP
2018-06-06Labeling · Supplement 5 · standard — Label ↗AP
2018-03-04Labeling · Supplement 4 · standard — Label ↗AP
2018-03-04Labeling · Supplement 2 · standard — Label ↗AP
2017-10-17Labeling · Supplement 1 · standard — Letter ↗AP
2016-04-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →