Is Voxelotor 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 Voxelotor.

Is Voxelotor approved by the US FDA?

Drugs@FDA lists 3 application product lines for Voxelotor, including OXBRYTA (Discontinued); OXBRYTA (Discontinued); OXBRYTA (Discontinued).

Is Voxelotor authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Voxelotor.

Are there safety signals or safety updates for Voxelotor?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2023-08-18).

Active substance

Voxelotor

SFDA 1
US FDA 3
EMA 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Oxbryta	500 mg	Film-coated tablet · Oral use	90 Bottle	SAR 26683.80	NCE · Prescription	Global Blood Therapeutics	Suspended · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OXBRYTA	500MG; 300MG	tablet · oral	GLOBAL BLOOD THERAPS	Discontinued	25 Nov 2019
OXBRYTA	300MG	tablet, for suspension · oral	GLOBAL BLOOD THERAPS	Discontinued	17 Dec 2021
OXBRYTA	500MG	tablet · oral	GLOBAL BLOOD THERAPS	Discontinued	17 Dec 2021

EMA European Union — centrally authorised medicines

Oxbryta Pfizer Europe MA EEIG · Suspended · authorised 14 Feb 2022 · ATC B06AX03

Therapeutic indication (EMA)

Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Safety signals and safety-related labeling changes

US FDA 18 Aug 2023 OXBRYTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Aug 2023 OXBRYTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 1 Sep 2022 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No

All safety entries for voxelotor →

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.