Fluoxetine
- Generic Name
- Fluoxetine
- Brand Names
- Prozac, Sarafem, Symbyax
- Drug Type
- Small Molecule
- Chemical Formula
- C17H18F3NO
- CAS Number
- 54910-89-3
- Unique Ingredient Identifier
- 01K63SUP8D
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.
Background
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 |
|---|---|---|---|---|---|
2011/11/28 | Not Applicable | Completed | |||
2011/09/20 | Phase 4 | Terminated | |||
2011/06/13 | Phase 3 | Completed | |||
2011/05/26 | Phase 3 | Completed | |||
2011/05/25 | Phase 4 | Completed | |||
2011/01/04 | Phase 2 | Completed | |||
2010/11/24 | Phase 1 | Completed | |||
2010/11/24 | Phase 1 | Completed | |||
2010/11/19 | Phase 1 | Completed | |||
2010/09/17 | Phase 4 | UNKNOWN |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 10 mg in 1 1 | 2024/01/25 | 59651-308 | ||
ORAL | 40 mg in 1 1 | 2024/01/26 | 72162-2221 | ||
ORAL | 10 mg in 1 1 | 2023/03/16 | 17224-171 | ||
ORAL | 20 mg in 1 1 | 2022/03/01 | 71205-975 | ||
ORAL | 10 mg in 1 1 | 2022/03/01 | 71205-974 | ||
ORAL | 10 mg in 1 1 | 2021/12/23 | 0777-3104 | ||
ORAL | 10 mg in 1 1 | 2022/10/01 | 63187-218 | ||
ORAL | 10 mg in 1 1 | 2023/08/01 | 62332-242 | ||
ORAL | 20 mg in 1 1 | 2023/08/01 | 62332-243 | ||
ORAL | 20 mg in 1 1 | 2023/05/25 | 71335-2020 |
EMA Approved Products
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HSA Approved Products
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NMPA Approved Products
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PPB Approved Products
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TGA Approved Products
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