Is Lefamulin approved by the US FDA?

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

Is Lefamulin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lefamulin: Xenleta.

Active substance

Lefamulin

US FDA 2
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
XENLETA	EQ 600MG BASE	tablet · oral	HONG KONG	Prescription	19 Aug 2019
XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	solution · intravenous	HONG KONG	Prescription	19 Aug 2019

EMA European Union — centrally authorised medicines

Xenleta Venipharm · Authorised · authorised 27 Jul 2020 · ATC J01XX

Therapeutic indication (EMA)

Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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.