Is Delafloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Delafloxacin, including Baxdela (300 mg, Powder for concentrate for solution for infusion, SAR 3219.00); Baxdela (450 mg, Tablet, SAR 4537.50).

Is Delafloxacin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Delafloxacin, including BAXDELA (Prescription); BAXDELA (Prescription).

Is Delafloxacin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Delafloxacin: Quofenix.

Are there safety signals or safety updates for Delafloxacin?

EMA PRAC: 5 entries; US FDA: 2 entries (latest 2023-12-01).

Active substance

Delafloxacin

SFDA 2
US FDA 2
EMA 1
Health Canada 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Baxdela	300 mg	Powder for concentrate for solution for infusion · Intravenous use	10 Vial	SAR 3219.00	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Baxdela	450 mg	Tablet · Oral use	20 Bottle	SAR 4537.50	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

COMMUNITY ACQUIRED PNEUMONEA

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

Product	Strength	Form · route	Applicant	Status	First approved
BAXDELA	EQ 450MG BASE	tablet · oral	MELINTA	Prescription	19 Jun 2017
BAXDELA	EQ 300MG BASE/VIAL	powder · intravenous	MELINTA	Prescription	19 Jun 2017

EMA European Union — centrally authorised medicines

Quofenix A. Menarini Industrie Farmaceutiche Riunite s.r.l. · Authorised · authorised 16 Dec 2019 · ATC J01MA23

Therapeutic indication (EMA)

Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (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)

Brand	DIN	Strength	Form · route	Company
BAXDELA	02554429	450 MG	TABLET · ORAL	XEDITON PHARMACEUTICALS INC
BAXDELA	02554437	300 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	XEDITON PHARMACEUTICALS INC

Safety signals and safety-related labeling changes

US FDA 1 Dec 2023 BAXDELA — 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 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes
EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
Action for MAH: update of the product information: No
US FDA 24 Oct 2019 BAXDELA — 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 delafloxacin →

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.