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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207318
Company: ACADIA PHARMS INC

Summary Review

Products on NDA 207318

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUPLAZID	PIMAVANSERIN TARTRATE	EQ 17MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
NUPLAZID	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207318

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207318Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207318Orig1s012;210793Orig1s009ltr.pdf
11/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207318Orig1s010, 210793Orig1s007ltr.pdf
09/27/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s009, 210793Orig1s003ltr.pdf
05/10/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s007, 210793Orig1s002ltr.pdf
03/04/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s006,210793Orig1s001ltr.pdf
06/06/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s005ltr.pdf
03/04/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf
06/28/2018	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf
03/04/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf
10/17/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207318Orig1s001ltr.pdf

Labels for NDA 207318

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf
11/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf
09/27/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf
05/10/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf
03/04/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf
06/28/2018	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf
06/06/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf
03/04/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf
03/04/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf
10/17/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf
04/29/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf

Therapeutic Equivalents for NDA 207318

NUPLAZID

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NUPLAZID	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	207318	ACADIA PHARMS INC
PIMAVANSERIN	PIMAVANSERIN TARTRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	214502	ZYDUS

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