Active substance
Insulin glargine recombinant
- US FDA 4
- US price lines 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LANTUS | 100 UNITS/ML | injectable · injection | SANOFI AVENTIS US | Prescription | 20 Apr 2000 |
| LANTUS SOLOSTAR | 300 UNITS/3ML (100 UNITS/ML) | injectable · injection | SANOFI AVENTIS US | Prescription | 20 Apr 2000 |
| TOUJEO SOLOSTAR | 450 UNITS/1.5ML (300 UNITS/ML) | solution · subcutaneous | SANOFI US SERVICES | Prescription | 25 Feb 2015 |
| TOUJEO MAX SOLOSTAR | 900 UNITS/3ML (300 UNITS/ML) | solution · subcutaneous | SANOFI US SERVICES | Prescription | 25 Feb 2015 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LANTUS SOLOSTAR 100 UNIT/ML | $6.16506 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 29 Aug 2024 TOUJEO MAX SOLOSTAR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Aug 2024 TOUJEO SOLOSTAR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Jun 2023 LANTUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Jun 2023 LANTUS SOLOSTAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.