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Sertraline

Generic Name
Sertraline
Brand Names
Zoloft
Drug Type
Small Molecule
Chemical Formula
C17H17Cl2N
CAS Number
79617-96-2
Unique Ingredient Identifier
QUC7NX6WMB

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.

Background

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
2016/06/27
Not Applicable
Terminated
2016/06/13
Phase 1
Completed
2016/05/19
Phase 4
Completed
2016/05/12
Phase 1
Completed
University of Ulm
2016/01/14
Not Applicable
Completed
2016/01/11
Phase 1
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2015/12/29
Phase 4
UNKNOWN
University Hospital Olomouc
2015/10/01
Phase 2
Completed
2015/08/13
Phase 4
Terminated
2015/07/22
Phase 4
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
71335-0896
ORAL
100 mg in 1 1
1/19/2022
Bryant Ranch Prepack
71335-0510
ORAL
100 mg in 1 1
9/15/2021
Unit Dose Services
50436-0011
ORAL
25 mg in 1 1
1/9/2019
RPK Pharmaceuticals, Inc.
53002-3215
ORAL
100 mg in 1 1
3/13/2023
NuCare Pharmaceuticals,Inc.
68071-4400
ORAL
50 mg in 1 1
1/17/2022
Exelan Pharmaceuticals, Inc.
76282-212
ORAL
25 mg in 1 1
9/1/2023
QPharma Inc
42708-124
ORAL
50 mg in 1 1
8/11/2023
NuCare Pharmaceuticals,Inc.
68071-4462
ORAL
25 mg in 1 1
2/22/2021
REMEDYREPACK INC.
70518-1040
ORAL
100 mg in 1 1
2/14/2024
Camber Pharmaceuticals, Inc.
31722-146
ORAL
50 mg in 1 1
6/22/2023

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
Dosage Form
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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