Overview
Sertraline is a popular antidepressant medication commonly known as a selective serotonin reuptake inhibitor (SSRI), and is similar to drugs such as Citalopram and Fluoxetine. Despite marked structural differences between compounds in this drug class, SSRIs exert similar pharmacological effects. Several weeks of therapy with sertraline may be required before beneficial effects are noticed. Sertraline displays enhanced safety or tolerability than other classes of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects.
Indication
Sertraline is indicated for the management of major depressive disorder (MDD), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), panic disorder (PD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder (SAD). Common off-label uses for sertraline include the prevention of post stroke depression, generalized anxiety disorder (GAD), fibromyalgia, premature ejaculation, migraine prophylaxis, diabetic neuropathy, and neurocardiogenic syncope.
Associated Conditions
- Binge Eating Disorder (BED)
- Bulimia Nervosa
- Generalized Anxiety Disorder
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Post Traumatic Stress Disorder (PTSD)
- Premenstrual Dysphoric Disorder (PMDD)
- Social Anxiety Disorder (SAD)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/06/12 | Not Applicable | UNKNOWN | Hospital Universitario Dr. Jose E. Gonzalez | ||
2020/05/14 | Phase 4 | Withdrawn | |||
2020/01/09 | Phase 4 | Recruiting | |||
2019/12/03 | Phase 4 | Terminated | |||
2019/11/22 | Phase 3 | Completed | |||
2019/11/20 | Phase 2 | UNKNOWN | |||
2019/10/11 | Phase 3 | Completed | |||
2019/09/19 | Phase 4 | Completed | |||
2019/08/28 | Phase 1 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2019/06/07 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 60687-242 | ORAL | 50 mg in 1 1 | 10/19/2023 | |
| American Health Packaging | 60687-253 | ORAL | 100 mg in 1 1 | 10/19/2023 | |
| West-ward Pharmaceutical Corp | 0143-9580 | ORAL | 100 mg in 1 1 | 10/11/2011 | |
| NuCare Pharmaceuticals, Inc. | 68071-3071 | ORAL | 50 mg in 1 1 | 2/11/2021 | |
| ROERIG | 0049-0050 | ORAL | 20 mg in 1 mL | 1/15/2023 | |
| Northwind Pharmaceuticals, LLC | 51655-345 | ORAL | 25 mg in 1 1 | 10/26/2023 | |
| REMEDYREPACK INC. | 70518-1350 | ORAL | 100 mg in 1 1 | 2/16/2024 | |
| REMEDYREPACK INC. | 70518-1615 | ORAL | 25 mg in 1 1 | 2/22/2024 | |
| Cipla USA Inc. | 69097-835 | ORAL | 100 mg in 1 1 | 3/8/2024 | |
| A-S Medication Solutions | 50090-3203 | ORAL | 100 mg in 1 1 | 2/6/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PPA-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack | 195317 | Medicine | A | 2/12/2013 | |
| DETRALON sertraline 100 mg tablet blister pack | 149401 | Medicine | A | 4/7/2009 | |
| DETRALON sertraline 100 mg tablet blister pack | 149401 | Medicine | A | 4/7/2009 | |
| SERTRALINE GENERICHEALTH sertraline 100mg (as hydrochloride) tablet blister pack | 124856 | Medicine | A | 9/6/2007 | |
| APOTEX-SERTRALINE sertraline (as hydrochloride) 100 mg tablet blister | 150242 | Medicine | A | 8/15/2008 | |
| SERTRALINE GENERICHEALTH sertraline 50mg (as hydrochloride) tablet blister pack | 124855 | Medicine | A | 9/6/2007 | |
| ELEVA 50 sertraline hydrochloride 50mg tablet blister pack | 95581 | Medicine | A | 7/29/2003 | |
| ELEVA 100 sertraline hydrochloride 100mg tablet blister pack | 95583 | Medicine | A | 7/29/2003 |
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