Regulatory PathRegulatory requirements compared

Active substance

Exenatide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BYETTA 10 mcg/ml solution for injection pre-filled pen10 µ/mlSolution for injection · Subcutaneous use1 Pre-filled penSAR 235.95NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
BYETTA 250 MCG/ML PRE - FIIED PEN250 µ/mlInjection · Subcutaneous use1 Pre-filled penSAR 511.30NCE · PrescriptionEli Lilly and CompanyWithdrawn by MAH · Not Marketed
BYETTA 250 MCG/ML PRE - FIIED PEN250 µ/mlInjection · Subcutaneous use1 Pre-filled penSAR 511.30NCE · PrescriptionEli Lilly and CompanyWithdrawn by MAH · Not Marketed
BYETTA 250 MCG/ML PRE - FIIED PEN250 µ/mlInjection · Subcutaneous use1 Pre-filled penSAR 511.30NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
BYETTA 250 MCG/ML PRE - FIIED PEN250 µ/mlInjection · Subcutaneous use1 Pre-filled penSAR 511.30NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
BYETTA 5 mcg/ml solution for injection pre-filled pen5 µ/mlSolution for injection · Subcutaneous use1 Pre-filled penSAR 165.15NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

Byetta AstraZeneca AB · Withdrawn · authorised 20 Nov 2006 · ATC A10BJ01

Therapeutic indication (EMA)

Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and a thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

Bydureon AstraZeneca AB · Withdrawn · authorised 17 Jun 2011 · ATC A10BJ01

Therapeutic indication (EMA)

Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACEXENATIDE 10 MCG DOSE PEN INJ$300.1675per ML22 Jul 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

All safety entries for exenatide →

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.