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.
Background
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 |
|---|---|---|---|---|---|
2024/08/09 | Early Phase 1 | Not yet recruiting | |||
2024/05/30 | Phase 4 | Recruiting | |||
2024/03/27 | Phase 3 | Recruiting | Foundation for Advancing Veterans' Health Research | ||
2024/01/11 | Not Applicable | Completed | Dr Rabia Arshad | ||
2023/10/02 | Phase 2 | Recruiting | Lone Baandrup | ||
2023/08/03 | Phase 3 | Recruiting | Dr. Inge Winter | ||
2023/05/03 | N/A | Recruiting | Central South University | ||
2023/04/06 | Not Applicable | Recruiting | |||
2023/03/31 | Phase 2 | Completed | |||
2022/11/02 | Phase 3 | Recruiting | Dr. Inge Winter |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SpecGx LLC | 0406-1180 | ORAL | 50 mg in 1 1 | 2/5/2014 | |
| A-S Medication Solutions | 50090-3342 | ORAL | 50 mg in 1 1 | 9/19/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7986 | ORAL | 25 mg in 1 1 | 2/9/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-612 | ORAL | 50 mg in 1 1 | 12/15/2023 | |
| Northstar RxLLC | 16714-454 | ORAL | 100 mg in 1 1 | 12/2/2022 | |
| Bryant Ranch Prepack | 63629-2479 | ORAL | 150 mg in 1 1 | 4/22/2020 | |
| Bryant Ranch Prepack | 71335-2157 | ORAL | 200 mg in 1 1 | 3/11/2022 | |
| ST. MARY'S MEDICAL PARK PHARMACY | 60760-866 | ORAL | 200 mg in 1 1 | 5/23/2025 | |
| A-S Medication Solutions | 50090-2420 | ORAL | 200 mg in 1 1 | 5/6/2021 | |
| 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 | SIN13839P | TABLET, FILM COATED | 100 mg | 7/26/2010 | |
| SEROQUEL TABLET 200 mg | SIN09771P | TABLET, FILM COATED | 200 mg | 5/16/1998 | |
| APO-QUETIAPINE TABLET 100MG | SIN14343P | TABLET, FILM COATED | 100MG | 4/25/2013 | |
| SEROQUEL TABLET 100 mg | SIN09767P | TABLET, FILM COATED | 100 mg | 5/16/1998 | |
| Ketipinor Tablet 200 mg | SIN13769P | TABLET, FILM COATED | 200 mg | 2/26/2010 | |
| Ketipinor Tablet 25 mg | SIN13767P | TABLET, FILM COATED | 25 mg | 2/26/2010 | |
| SEROQUEL TABLET 25 mg | SIN09766P | TABLET, FILM COATED | 25 mg | 5/16/1998 | |
| SAQUIN SR PROLONGED-RELEASE TABLETS 300MG | SIN16692P | TABLET, EXTENDED RELEASE | 300.000mg | 2/14/2023 | |
| Seroquel XR Tablet 50mg | SIN13502P | TABLET, EXTENDED RELEASE | 50 mg | 7/29/2008 | |
| Seroquel XR Tablet 300mg | SIN13504P | TABLET, EXTENDED RELEASE | 300 mg | 7/29/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Quetiapine Fumarate Tablets | 国药准字H20258051 | 化学药品 | 片剂 | 4/2/2025 | |
| Quetiapine Fumarate Tablets | 国药准字H20213870 | 化学药品 | 片剂 | 11/17/2021 | |
| Quetiapine Fumarate Tablets | 国药准字H20258052 | 化学药品 | 片剂 | 4/2/2025 | |
| Quetiapine Fumarate Tablets | 国药准字H20213873 | 化学药品 | 片剂 | 11/17/2021 | |
| Quetiapine Fumarate Tablets | 国药准字H20070040 | 化学药品 | 片剂 | 6/5/2020 | |
| Quetiapine Fumarate Tablets | 国药准字H20233800 | 化学药品 | 片剂 | 9/28/2023 | |
| Quetiapine Fumarate Tablets | 国药准字H20203368 | 化学药品 | 片剂 | 7/29/2020 | |
| Quetiapine Fumarate Tablets | 国药准字H20133105 | 化学药品 | 片剂 | 6/5/2020 | |
| Quetiapine Fumarate Tablets | 国药准字H20030741 | 化学药品 | 片剂 | 6/5/2020 | |
| Quetiapine Fumarate Tablets | 国药准字H20133106 | 化学药品 | 片剂 | 6/5/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| QUETIAPINE TABLETS 100MG | N/A | N/A | N/A | 12/18/2017 | |
| QUETIAPINE TABLETS 300MG | N/A | N/A | N/A | 8/28/2018 | |
| SEROGEN TABLETS 25MG | N/A | N/A | N/A | 12/30/2017 | |
| SETININ TABLETS 100MG | N/A | N/A | N/A | 9/12/2012 | |
| QUETIAPINE-TEVA TAB 100MG | N/A | N/A | N/A | 9/28/2009 | |
| QUETIAPINE TABLETS 25MG | N/A | N/A | N/A | 12/18/2017 | |
| QUETIAPINE TABLETS 25MG | N/A | N/A | N/A | 8/28/2018 | |
| QUETIAPINE TABLETS 100MG | N/A | 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 | Medicine | A | 1/17/2014 | |
| QUALEZ quetiapine (as fumarate salt) 100mg tablet blister pack | 178490 | Medicine | A | 6/24/2011 | |
| TIAVA XR quetiapine (as fumarate) 300 mg modified release tablet blister pack | 249992 | Medicine | A | 7/14/2016 | |
| QUETIAPINE RANBAXY quetiapine (as fumarate) 100mg tablet blister pack | 166428 | Medicine | A | 3/11/2011 | |
| QUETIAPINE RANBAXY quetiapine (as fumarate) 100mg tablet strip pack | 166430 | Medicine | A | 3/11/2011 | |
| QUETIAQUEL Sandoz XR quetiapine (as fumarate) 150 mg modified release tablet blister | 346815 | Medicine | A | 9/17/2021 | |
| QUETIAPINE SPR quetiapine (as fumarate) 100 mg tablet blister pack | 384122 | Medicine | A | 5/27/2022 | |
| SYQUET quetiapine (as fumarate) 100 mg tablet blister pack | 203592 | Medicine | A | 4/2/2014 | |
| PHARMACOR QUETIAPINE 300 quetiapine (as fumarate) 300mg film-coated tablet blister pack | 204824 | Medicine | A | 2/13/2014 | |
| AURO-QUETIAPINE 200 | 172857 | Medicine | A | 10/18/2011 |