Is Daunorubicin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Daunorubicin.

Is Daunorubicin approved by the US FDA?

Drugs@FDA lists 11 application product lines for Daunorubicin, including CERUBIDINE (Prescription); DAUNORUBICIN HYDROCHLORIDE (Prescription); DAUNORUBICIN HYDROCHLORIDE (Prescription); DAUNORUBICIN HYDROCHLORIDE (Prescription); DAUNORUBICIN HYDROCHLORIDE (Prescription).

Is Daunorubicin on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Acute myeloid leukaemia with recurrent genetic abnormalities; Lymphoid leukaemia, not elsewhere classified; Myeloid leukaemia.

Are there safety signals or safety updates for Daunorubicin?

US FDA: 1 entry (latest 2026-01-27).

Active substance

Daunorubicin

SFDA 1
US FDA 11
Health Canada 3
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DAUNOBLASTINA 20MG VIAL+SOLV	20 mg	Solution · Intravenous use	1 Vial	SAR 29.90	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
CERUBIDINE	EQ 20MG BASE/VIAL	injectable · injection	HIKMA PHARMS	Prescription	3 Feb 1995
DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	30 Jan 1998
DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	25 May 1999
DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	injectable · injection	MEITHEAL	Prescription	24 Jan 2000
DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	injectable · injection	HISUN PHARM HANGZHOU	Prescription	12 Apr 2019
CERUBIDINE	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	WYETH AYERST	Discontinued	19 Dec 1979
CERUBIDINE	EQ 20MG BASE/VIAL	injectable · injection	SANOFI AVENTIS US	Discontinued	5 Feb 1980
DAUNOXOME	EQ 2MG BASE/ML	injectable, liposomal · injection	GALEN (UK)	Discontinued	8 Apr 1996
DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL; EQ 50MG BASE/VIAL	injectable · injection	TEVA PARENTERAL	Discontinued	23 Jun 1998
DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Discontinued	20 Nov 2001
DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL	injectable · injection	HISUN PHARM HANGZHOU	Discontinued	25 Apr 2019

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CERUBIDINE	01926683	20 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SEARCHLIGHT PHARMA INC
DAUNORUBICIN HYDROCHLORIDE INJECTION	02539209	20 MG / 4 ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED
DAUNORUBICIN INJECTABLE SOLUTION	02501481	50 MG / 10 ML	SOLUTION · INTRAVENOUS	GENERIC MEDICAL PARTNERS INC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Acute myeloid leukaemia with recurrent genetic abnormalities; Lymphoid leukaemia, not elsewhere classified; Myeloid leukaemia
Parenteral > General injections > IV: 50 mg in vial (as hydrochloride) powder for injection; 20 mg in vial (as hydrochloride) powder for injection; 2 mg per mL in vial (as hydrochloride); 5 mg per mL in vial (as hydrochloride)

Safety signals and safety-related labeling changes

US FDA 27 Jan 2026 VYXEOS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for daunorubicin →

Combinations containing Daunorubicin

Cytarabine + daunorubicin

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.