TheraRadar
Data updated: May 26, 2026

TENOFOVIR ALAFENAMIDE FUMARATE

Infectious Disease Approved 2024-03-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2024-03-21
Routes
ORAL
Dosage Forms
TABLET

Companies

LAURUS LABS LTD Apotex
Active Ingredient: TENOFOVIR ALAFENAMIDE FUMARATE

TENOFOVIR ALAFENAMIDE FUMARATE Approval History

2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Mar 2024 ORIGINAL
Update
FDA Letter

What TENOFOVIR ALAFENAMIDE FUMARATE Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

TENOFOVIR ALAFENAMIDE FUMARATE FDA Label Details

Looking for the branded version?

VEMLIDY

Full clinical data, patents, trials, and competitive landscape for tenofovir alafenamide fumarate.

See VEMLIDY

Data Sources

FDA Approval: ANDA214030 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.