SELFEMRA (fluoxetine hydrochloride) · Teva
SELFEMRA is FDA-approved to treat 6 conditions (same as PROZAC).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2014-02-03
- Routes
- ORAL
- Dosage Forms
- TABLET
SELFEMRA Approval History
What SELFEMRA Treats
6 indicationsSELFEMRA is approved for 6 conditions since its original approval in 2014. 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
Same approved indications as PROZAC (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
SELFEMRA FDA Label Details
Indications & Usage
SELFEMRA is FDA-approved to treat 6 conditions — same approved indications as PROZAC.
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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