Overview
Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.
Indication
Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present. Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression. Fluoxetine is additionally indicated for the treatment of female patients with premenstrual dysphoric disorder (PMDD).
Associated Conditions
- Alcohol Dependency
- Anorexia Nervosa (AN)
- Bulimia Nervosa
- Cataplexy
- Depression
- Major Depressive Disorder (MDD)
- Major depressive disorder, recurrent episode
- Myoclonus
- Obesity
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder With Agoraphobia
- Panic disorder without agoraphobia
- Premature Ejaculation
- Premenstrual Dysphoric Disorder (PMDD)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/10/23 | Phase 1 | Completed | |||
2013/10/16 | Phase 2 | Withdrawn | |||
2013/07/29 | Phase 2 | Completed | |||
2013/07/11 | Not Applicable | UNKNOWN | |||
2013/04/04 | Phase 4 | Completed | Capital Medical University | ||
2013/03/11 | Phase 3 | Completed | |||
2013/03/11 | Phase 3 | Completed | |||
2013/03/01 | Phase 1 | Completed | |||
2013/01/10 | Phase 4 | UNKNOWN | |||
2012/12/04 | Not Applicable | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-3483 | ORAL | 10 mg in 1 1 | 1/12/2024 | |
| American Health Packaging | 60687-244 | ORAL | 20 mg in 5 mL | 1/24/2024 | |
| Northwind Pharmaceuticals | 51655-314 | ORAL | 10 mg in 1 1 | 1/1/2023 | |
| Dista Products Company | 0777-3105 | ORAL | 20 mg in 1 1 | 12/23/2021 | |
| TWi Pharmaceuticals, Inc. | 24979-255 | ORAL | 60 mg in 1 1 | 12/29/2023 | |
| Dr.Reddy's Laboratories Limited | 55111-150 | ORAL | 10 mg in 1 1 | 8/31/2023 | |
| NuCare Pharmaceuticals,Inc.w | 68071-3484 | ORAL | 20 mg in 1 1 | 10/13/2023 | |
| STAT RX USA LLC | 16590-100 | ORAL | 20 mg in 1 1 | 7/19/2010 | |
| Life Line Home Care Services, Inc. | 75921-648 | ORAL | 20 mg in 1 1 | 1/16/2012 | |
| Contract Pharmacy Services-PA | 67046-210 | ORAL | 10 mg in 1 1 | 3/26/2009 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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