Is Crisaborole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Crisaborole, including Staquis (2 %, Ointment, SAR 340.30).

Is Crisaborole approved by the US FDA?

Drugs@FDA lists 2 application product lines for Crisaborole, including EUCRISA (Prescription); CRISABOROLE (Prescription).

Is Crisaborole authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Crisaborole.

Are there safety signals or safety updates for Crisaborole?

US FDA: 1 entry (latest 2023-04-03).

Active substance

Crisaborole

SFDA 1
US FDA 2
EMA 1
Health Canada 1
US price lines 2
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
Staquis	2 %	Ointment · Topical	1 Tube	SAR 340.30	NCE · Prescription	PFIZER INC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
EUCRISA	2%	ointment · topical	ANACOR PHARMS INC	Prescription	14 Dec 2016
CRISABOROLE	2%	ointment · topical	MACLEODS PHARMS	Prescription	24 Sep 2026

EMA European Union — centrally authorised medicines

Staquis Pfizer Europe MA EEIG · Withdrawn · authorised 27 Mar 2020 · ATC D11AH06

Therapeutic indication (EMA)

Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ? 40% body surface area (BSA) affected.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EUCRISA	02476991	2 % / W/W	OINTMENT · TOPICAL	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	EUCRISA 2% OINTMENT	$10.7089	per GM	23 Sep 2026
US NADAC	EUCRISA 2% OINTMENT	$12.64647	per GM	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 3 Apr 2023 EUCRISA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for crisaborole →

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.