Data updated: May 26, 2026
TOUJEO MAX SOLOSTAR (insulin glargine recombinant)
Metabolic
Approved 2015-02-25
2
Indications
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-02-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TOUJEO MAX SOLOSTAR Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2015 to 2024 · 1 indication expansions
Nov 2016 SUPPL
Mfg
Feb 2016 SUPPL
Mfg
What TOUJEO MAX SOLOSTAR Treats
2 FDA approvalsOriginally approved for its first indication in 2015 . Covers 2 distinct patient populations.
- Other (2)
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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| NCT00943709 | 060601 AVENTIS-CINJ-060601, 0220070268 | Ph 3 | withdrawn | Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
TOUJEO MAX SOLOSTAR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.