Regulatory PathRegulatory requirements compared

Active substance

Dalbavancin

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DALVANCEEQ 500MG BASE/VIALpowder · intravenousABBVIEPrescription23 May 2014
DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALpowder · intravenousTEVA PHARMS INCPrescription23 Oct 2025
DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALpowder · intravenousFRESENIUS KABI USAPrescription10 Nov 2025
DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALpowder · intravenousKINDOSPrescription26 Nov 2025
DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALpowder · intravenousLONG GROVE PHARMSPrescription26 Feb 2026
DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALpowder · intravenousBE PHARMSPrescription4 Jun 2026

EMA European Union — centrally authorised medicines

Xydalba AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 19 Feb 2015 · ATC J01XA04

Therapeutic indication (EMA)

Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
XYDALBA02480522500 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSKNIGHT THERAPEUTICS INC.

Safety signals and safety-related labeling changes

  • US FDA 22 Jul 2021 DALVANCE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for dalbavancin →

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.