Is Saxagliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Saxagliptin, including Glipza (5 mg, Film-coated tablet, SAR 98.25).

Is Saxagliptin approved by the US FDA?

Drugs@FDA lists 6 application product lines for Saxagliptin, including SAXAGLIPTIN (Prescription); SAXAGLIPTIN (Prescription); SAXAGLIPTIN (Prescription); ONGLYZA (Discontinued); SAXAGLIPTIN (Discontinued).

Is Saxagliptin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Saxagliptin: Onglyza.

Are there safety signals or safety updates for Saxagliptin?

EMA PRAC: 7 entries; US FDA: 4 entries (latest 2026-08-11).

Active substance

Saxagliptin

SFDA 3
US FDA 6
EMA 1
Health Canada 6
US price lines 2
NHS prices 2
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Glipza	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.25	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ONGLYZA 2.5 MG TABLET	2.5 mg	Tablet · Oral use	30 Blister	SAR 52.60	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed
ONGLYZA 5 MG TABLET	5 mg	Tablet · Oral use	30 Blister	SAR 105.30	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SAXAGLIPTIN	EQ 2.5MG BASE; EQ 5MG BASE	tablet · oral	AUROBINDO PHARMA	Prescription	31 Jul 2023
SAXAGLIPTIN	EQ 2.5MG BASE; EQ 5MG BASE	tablet · oral	MYLAN	Prescription	31 Jul 2023
SAXAGLIPTIN	EQ 2.5MG BASE; EQ 5MG BASE	tablet · oral	GLENMARK PHARMS LTD	Prescription	31 Jul 2023
ONGLYZA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	ASTRAZENECA AB	Discontinued	31 Jul 2009
SAXAGLIPTIN	EQ 2.5MG BASE; EQ 5MG BASE	tablet · oral	AMNEAL	Discontinued	31 Jul 2023
SAXAGLIPTIN	EQ 2.5MG BASE; EQ 5MG BASE	tablet · oral	SUN PHARM	Discontinued	31 Jul 2023

EMA European Union — centrally authorised medicines

Onglyza AstraZeneca AB · Authorised · authorised 30 Sep 2009 · ATC A10BH03

Therapeutic indication (EMA)

Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; as triple oral therapy: in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-SAXAGLIPTIN	02507471	2.5 MG	TABLET · ORAL	APOTEX INC
APO-SAXAGLIPTIN	02507498	5 MG	TABLET · ORAL	APOTEX INC
ONGLYZA	02333554	5 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
ONGLYZA	02375842	2.5 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
SANDOZ SAXAGLIPTIN	02468603	2.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ SAXAGLIPTIN	02468611	5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SAXAGLIPTIN HCL 2.5 MG TABLET	$1.14446	per EA	23 Sep 2026
US NADAC	SAXAGLIPTIN HCL 5 MG TABLET	$1.03871	per EA	23 Sep 2026
NHS Drug Tariff	Saxagliptin 2.5mg tablets	£31.60	28 tablet	1 Oct 2026
NHS Drug Tariff	Saxagliptin 5mg tablets	£31.60	28 tablet	1 Oct 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 11 Aug 2026 KOMBIGLYZE XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 3 Jun 2026 QTERN — 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
EMA PRAC 7 May 2026 PRAC signal: Lichen sclerosus
Action for MAH: update of the product information: No
US FDA 11 Oct 2024 ONGLYZA — 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
EMA PRAC 14 May 2020 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
US FDA 24 Jan 2020 QTERNMET XR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 Jan 2020 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 17 Jan 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No
EMA PRAC 9 Jul 2015 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No

All safety entries for saxagliptin →

Combinations containing Saxagliptin

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.