Quetiapine

Overview

Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder. Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as Clozapine and Olanzapine.

Indication

Quetiapine is used in the symptomatic treatment of schizophrenia. In addition, it may be used for the management of acute manic or mixed episodes in patients with bipolar I disorder, as a monotherapy or combined with other drugs. It may be used to manage depressive episodes in bipolar disorder. In addition to the above indications, quetiapine is used in combination with antidepressant drugs for the treatment of major depression. Some off-label uses for this drug include the management of post-traumatic stress disorder (PTSD), generalized anxiety disorder, and psychosis associated with Parkinson's disease.

Associated Conditions

Bipolar 1 Disorder
Depressive Episodes
Generalized Anxiety Disorder
Major Depressive Disorder (MDD)
Mixed manic depressive episode
Post Traumatic Stress Disorder (PTSD)
Psychosis
Schizophrenia
Acute Manic episode

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Quetiapine Versus Trazadone in Women With Postpartum Depression	2024/08/09	NCT06546358	Early Phase 1	Not yet recruiting	Lawson Health Research Institute
Sequential Multiple Assignment Randomized Trial for Bipolar Depression	2024/05/30	NCT06433635	Phase 4	Recruiting	Massachusetts General Hospital
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)	2024/03/27	NCT06333990	Phase 3	Recruiting	Foundation for Advancing Veterans' Health Research
Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics	2024/01/11	NCT06200584	Not Applicable	Completed	Dr Rabia Arshad
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia	2023/10/02	NCT06062953	Phase 2	Recruiting	Lone Baandrup
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.	2023/08/03	NCT05973786	Phase 3	Recruiting	Dr. Inge Winter
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders	2023/05/03	NCT05840861	N/A	Recruiting	Central South University
Quetiapine as Prophylaxis for Delirium in CABG	2023/04/06	NCT05801289	Not Applicable	Recruiting	Ain Shams University
Quetiapine in Prevention of Delirium	2023/03/31	NCT05793632	Phase 2	Completed	Ain Shams University
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure	2022/11/02	NCT05603104	Phase 3	Recruiting	Dr. Inge Winter

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Quetiapine Fumarate Extended-Release	SpecGx LLC	0406-1180	ORAL	50 mg in 1 1	2/5/2014
Quetiapine Fumarate	A-S Medication Solutions	50090-3342	ORAL	50 mg in 1 1	9/19/2023
Quetiapine	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7986	ORAL	25 mg in 1 1	2/9/2023
Quetiapine fumarate	Lupin Pharmaceuticals, Inc.	68180-612	ORAL	50 mg in 1 1	12/15/2023
Quetiapine	Northstar RxLLC	16714-454	ORAL	100 mg in 1 1	12/2/2022
Quetiapine Extended Release	Bryant Ranch Prepack	63629-2479	ORAL	150 mg in 1 1	4/22/2020
Quetiapine fumarate	Bryant Ranch Prepack	71335-2157	ORAL	200 mg in 1 1	3/11/2022
Quetiapine Extended Release	ST. MARY'S MEDICAL PARK PHARMACY	60760-866	ORAL	200 mg in 1 1	5/23/2025
Quetiapine	A-S Medication Solutions	50090-2420	ORAL	200 mg in 1 1	5/6/2021
Quetiapine Extended Release	ACI Healthcare USA, Inc.	71093-137	ORAL	200 mg in 1 1	4/22/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Quetiapine Sandoz 100 mg Tablets	Genveon Ilac Sanayi ve Ticaret A.S.	SIN13839P	TABLET, FILM COATED	100 mg	7/26/2010
SEROQUEL TABLET 200 mg	ASTRAZENECA UK LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN09771P	TABLET, FILM COATED	200 mg	5/16/1998
APO-QUETIAPINE TABLET 100MG	APOTEX INC.	SIN14343P	TABLET, FILM COATED	100MG	4/25/2013
SEROQUEL TABLET 100 mg	ASTRAZENECA UK LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN09767P	TABLET, FILM COATED	100 mg	5/16/1998
Ketipinor Tablet 200 mg	Orion Corporation (Espoo), Orion Corporation (Salo) (Primary & Secondary Packager)	SIN13769P	TABLET, FILM COATED	200 mg	2/26/2010
Ketipinor Tablet 25 mg	Orion Corporation (Espoo), Orion Corporation (Salo) (Primary & Secondary Packager)	SIN13767P	TABLET, FILM COATED	25 mg	2/26/2010
SEROQUEL TABLET 25 mg	ASTRAZENECA UK LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN09766P	TABLET, FILM COATED	25 mg	5/16/1998
SAQUIN SR PROLONGED-RELEASE TABLETS 300MG	PHARMATHEN INTERNATIONAL S.A, PHARMATHEN S.A. (Primary and Secondary Packager)	SIN16692P	TABLET, EXTENDED RELEASE	300.000mg	2/14/2023
Seroquel XR Tablet 50mg	AstraZeneca UK Limited (Manufacture, QC testing, packing, final release), AstraZeneca Pharmaceuticals LP (Manufacture, QC testing and release of bulk product)	SIN13502P	TABLET, EXTENDED RELEASE	50 mg	7/29/2008
Seroquel XR Tablet 300mg	AstraZeneca UK Limited (Manufacture, QC testing, packing, final release), AstraZeneca Pharmaceuticals LP (Manufacture, QC testing and release of bulk product)	SIN13504P	TABLET, EXTENDED RELEASE	300 mg	7/29/2008

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
QUETIAPINE TABLETS 100MG	N/A	HONG KONG MEDICAL SUPPLIES LIMITED	N/A	N/A	12/18/2017
QUETIAPINE TABLETS 300MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/28/2018
SEROGEN TABLETS 25MG	N/A	LSB (HK) LIMITED	N/A	N/A	12/30/2017
SETININ TABLETS 100MG	N/A	TEVA PHARMACEUTICAL HONG KONG LIMITED	N/A	N/A	9/12/2012
QUETIAPINE-TEVA TAB 100MG	N/A	TEVA PHARMACEUTICAL HONG KONG LIMITED	N/A	N/A	9/28/2009
QUETIAPINE TABLETS 25MG	N/A	HONG KONG MEDICAL SUPPLIES LIMITED	N/A	N/A	12/18/2017
QUETIAPINE TABLETS 25MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/28/2018
QUETIAPINE TABLETS 100MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/28/2018

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
QUETIA XR quetiapine (as fumarate) 50mg modified release tablet blister pack	199878	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/17/2014
QUALEZ quetiapine (as fumarate salt) 100mg tablet blister pack	178490	Luye Pharma Australia Pty Ltd	Medicine	A	6/24/2011
TIAVA XR quetiapine (as fumarate) 300 mg modified release tablet blister pack	249992	Medis Pharma Pty Ltd	Medicine	A	7/14/2016
QUETIAPINE RANBAXY quetiapine (as fumarate) 100mg tablet blister pack	166428	Sun Pharma ANZ Pty Ltd	Medicine	A	3/11/2011
QUETIAPINE RANBAXY quetiapine (as fumarate) 100mg tablet strip pack	166430	Sun Pharma ANZ Pty Ltd	Medicine	A	3/11/2011
QUETIAQUEL Sandoz XR quetiapine (as fumarate) 150 mg modified release tablet blister	346815	Accord Healthcare Pty Ltd	Medicine	A	9/17/2021
QUETIAPINE SPR quetiapine (as fumarate) 100 mg tablet blister pack	384122	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/27/2022
SYQUET quetiapine (as fumarate) 100 mg tablet blister pack	203592	Accord Healthcare Pty Ltd	Medicine	A	4/2/2014
PHARMACOR QUETIAPINE 300 quetiapine (as fumarate) 300mg film-coated tablet blister pack	204824	Pharmacor Pty Ltd	Medicine	A	2/13/2014
AURO-QUETIAPINE 200	172857	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/18/2011

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
QUETIAPINA COMBIX 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Combix S.L.U.	73976	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUETIAPINA TARBIS 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tarbis Farma S.L.	70199	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUETIAPINA TARBIS 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tarbis Farma S.L.	70195	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUETIAPINA SANDOZ FARMACEUTICA 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	70180	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUDIX 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Adamed Laboratorios S.L.U.	70168	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUETIAPINA SANDOZ FARMACEUTICA 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	70183	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUETIAPINA COMBIX 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Combix S.L.U.	73981	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
QUDIX 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Adamed Laboratorios S.L.U.	70171	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ATROLAK PROLONG 50 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG	Accord Healthcare S.L.U.	77977	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
QUETIAPINA TARBIS 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tarbis Farma S.L.	70197	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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