Active substance
Insulin glulisine recombinant
- US FDA 3
- US price lines 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| APIDRA | 1000 UNITS/10ML (100 UNITS/ML) | injectable · intravenous, subcutaneous | SANOFI AVENTIS US | Prescription | 16 Apr 2004 |
| APIDRA SOLOSTAR | 300 UNITS/3ML | injectable · subcutaneous | SANOFI AVENTIS US | Prescription | 16 Apr 2004 |
| APIDRA | 300 UNITS/3ML (100 UNITS/ML) | injectable · intravenous, subcutaneous | SANOFI AVENTIS US | Discontinued | 16 Apr 2004 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | APIDRA SOLOSTAR 100 UNIT/ML | $10.50102 | 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 30 Nov 2022 APIDRA — 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 15 Nov 2019 APIDRA 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.