TOUJEO MAX SOLOSTAR (insulin glargine recombinant) · Sanofi
TOUJEO MAX SOLOSTAR is FDA-approved to treat 1 condition (same as LANTUS SOLOSTAR).
Details
- Status
- Prescription
- First Approved
- 2015-02-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TOUJEO MAX SOLOSTAR Approval History
What TOUJEO MAX SOLOSTAR Treats
1 indicationsTOUJEO MAX SOLOSTAR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as LANTUS SOLOSTAR (same active ingredient).
Sanofi'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 |
|---|---|---|---|---|
| NCT00943709 | 060601 AVENTIS-CINJ-060601, 0220070268 | Ph 3 | withdrawn | Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia |
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.
TOUJEO MAX SOLOSTAR FDA Label Details
Indications & Usage
FDA Label (PDF)TOUJEO MAX SOLOSTAR is FDA-approved to treat 1 condition — same approved indications as LANTUS SOLOSTAR.
Track TOUJEO MAX SOLOSTAR with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.