TheraRadar
Data updated: May 26, 2026

SELFEMRA (fluoxetine hydrochloride)

Trial Activity: Declining 13 active trials
CNS Approved 2014-02-03
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Eli Lilly and Company conducting 8 trials (11%)
64 indications explored (Broad Platform)
→ depression (14 trials)
→ major depressive disorder (12 trials)
→ anxiety disorders (3 trials)
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2014-02-03
Routes
ORAL
Dosage Forms
TABLET

Companies

Teva
Active Ingredient: FLUOXETINE HYDROCHLORIDE

SELFEMRA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2014 to 2023
Aug 2023 SUPPL
Label · Labeling
Aug 2023 SUPPL
Label · Labeling
Sep 2021 SUPPL
Label · Labeling

What SELFEMRA Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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Data Sources

FDA Approval: ANDA200151 → Trials: ClinicalTrials.gov →

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