PROZAC (fluoxetine hydrochloride)
PROZAC is indicated for the treatment of Major Depressive Disorder; Obsessive Compulsive Disorder; Bulimia Nervosa; Panic Disorder; Bipolar I Disorder; Treatment Resistant Depression.
How PROZAC Works
Although the exact mechanism of Prozac is unknown, its clinical effects are presumed to be linked to the inhibition of serotonin uptake. Specifically, the drug inhibits the neuronal uptake of serotonin within the central nervous system. This action characterizes the drug as a selective serotonin reuptake inhibitor.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1987-12-29
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, CAPSULE
PROZAC Approval History
What PROZAC Treats
6 indicationsPROZAC is approved for 6 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Bulimia Nervosa
- Panic Disorder
- Bipolar I Disorder
- Treatment Resistant Depression
PROZAC Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1 )] . In patients of all ages who are started on antidepressant therapy, monitor...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1 )] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1 )] . PROZAC is not approved for use in children less than 7 years of age [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . When using PROZAC and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ). Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). When using PROZAC and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax .
PROZAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PROZAC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03448159 FLOW | 18-6002 CTO #1465 | Ph 2 | completed | Fluoxetine Opens Window to Improve Motor Recovery After Stroke |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROZAC FDA Label Details
Indications & Usage
FDA Label (PDF)PROZAC is indicated for the treatment of Major Depressive Disorder; Obsessive Compulsive Disorder; Bulimia Nervosa; Panic Disorder; Bipolar I Disorder; Treatment Resistant Depression.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients ove...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment