Is Pretomanid approved by the US FDA?

Drugs@FDA lists 1 application product line for Pretomanid, including PRETOMANID (Prescription).

Is Pretomanid authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pretomanid: Dovprela (previously Pretomanid FGK).

Is Pretomanid on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Multi-drug resistant Mycobacterium tuberculosis.

Are there safety signals or safety updates for Pretomanid?

US FDA: 1 entry (latest 2024-11-22).

Active substance

Pretomanid

US FDA 1
EMA 1
WHO EML 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
PRETOMANID	200MG	tablet · oral	MYLAN IRELAND LTD	Prescription	14 Aug 2019

EMA European Union — centrally authorised medicines

Dovprela (previously Pretomanid FGK) Mylan IRE Healthcare Limited · Authorised · authorised 31 Jul 2020 · ATC J04

Therapeutic indication (EMA)

Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > tablet: 200 mg

Safety signals and safety-related labeling changes

US FDA 22 Nov 2024 PRETOMANID — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pretomanid →

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.