RALTEGRAVIR POTASSIUM · Lupin
RALTEGRAVIR POTASSIUM is FDA-approved to treat 1 condition (same as ISENTRESS).
Details
- Status
- Prescription
- First Approved
- 2007-10-12
- Routes
- ORAL
- Dosage Forms
- TABLET
RALTEGRAVIR POTASSIUM Approval History
What RALTEGRAVIR POTASSIUM Treats
1 indicationsRALTEGRAVIR POTASSIUM is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ISENTRESS (same active ingredient).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01022476 LIVERAL | ANRS 148 LIVERAL 2009-014616-36 | Ph 1, Ph 2 | completed | Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients |
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.
RALTEGRAVIR POTASSIUM FDA Label Details
Indications & Usage
RALTEGRAVIR POTASSIUM is FDA-approved to treat 1 condition — same approved indications as ISENTRESS.
Looking for the branded version?
ISENTRESS
Full clinical data, patents, trials, and competitive landscape for raltegravir potassium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.