Active substance
Exenatide synthetic
- US FDA 6
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BYETTA | 300UGM/1.2ML (250UGM/ML); 600UGM/2.4ML (250UGM/ML) | injectable · subcutaneous | AMYLIN | Prescription | 30 Oct 2009 |
| EXENATIDE SYNTHETIC | 300MCG/1.2ML (250MCG/ML); 600MCG/2.4ML (250MCG/ML) | injectable · subcutaneous | AMNEAL | Prescription | 19 Nov 2024 |
| BYETTA | 300MCG/1.2ML (250MCG/ML); 600MCG/2.4ML (250MCG/ML) | injectable · subcutaneous | ASTRAZENECA AB | Discontinued | 28 Apr 2005 |
| BYDUREON | 2MG/VIAL | for suspension, extended release · subcutaneous | ASTRAZENECA AB | Discontinued | 27 Jan 2012 |
| BYDUREON PEN | 2MG | for suspension, extended release · subcutaneous | ASTRAZENECA AB | Discontinued | 27 Jan 2012 |
| BYDUREON BCISE | 2MG/0.85ML (2MG/0.85ML) | suspension, extended release · subcutaneous | ASTRAZENECA AB | Discontinued | 20 Oct 2017 |
Safety signals and safety-related labeling changes
- US FDA 28 May 2025 BYDUREON — 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 28 May 2025 BYETTA — 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
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.