Is Dapagliflozin + Metformin + Saxagliptin approved by the US FDA?

Drugs@FDA lists 1 application product line for Dapagliflozin + Metformin + Saxagliptin, including QTERNMET XR (Discontinued).

Is Dapagliflozin + Metformin + Saxagliptin authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Dapagliflozin + Metformin + Saxagliptin.

Active substances

Dapagliflozin + Metformin + Saxagliptin

US FDA 1
EMA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE; 5MG;1GM;EQ 2.5MG BASE; 5MG;1GM;EQ 5MG BASE; 10MG;1GM;EQ 5MG BASE	tablet, extended release · oral	ASTRAZENECA AB	Discontinued	2 May 2019

EMA European Union — centrally authorised medicines

Qtrilmet AstraZeneca AB · Withdrawn · authorised 11 Nov 2019 · ATC A10BD

Therapeutic indication (EMA)

Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control. when already being treated with metformin and saxagliptin and dapagliflozin.

Components

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.