Is Roflumilast 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 Roflumilast, including ROFLAST 500 mcg (500 µg, Film-coated tablet, SAR 109.20).

Is Roflumilast approved by the US FDA?

Drugs@FDA lists 14 application product lines for Roflumilast, including DALIRESP (Prescription); ROFLUMILAST (Prescription); ROFLUMILAST (Prescription); ROFLUMILAST (Prescription); ROFLUMILAST (Prescription).

Is Roflumilast authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Roflumilast: Daxas.

Are there safety signals or safety updates for Roflumilast?

US FDA: 3 entries; MHRA: 1 entry (latest 2026-06-29).

Active substance

Roflumilast

SFDA 5
US FDA 14
EMA 3
Health Canada 5
US price lines 8
NHS prices 2
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ROFLAST 500 mcg	500 µg	Film-coated tablet · Oral use	30 Blister	SAR 109.20	Generic · Prescription	SPIMACO ADDWAEIH	Valid
DAXAS 500MCG F.C. TABLET	500 µg	Film-coated tablet · Oral use	90 Blister	SAR 385.50	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed
DAXAS 500MCG F.C. TABLET	500 µg	Film-coated tablet · Oral use	30 Blister	SAR 218.15	NCE · Prescription	TAKEDA GMBH	Withdrawn by MAH · Not Marketed
DAXAS 500MCG F.C. TABLET	500 µg	Film-coated tablet · Oral use	90 Blister	SAR 654.50	NCE · Prescription	TAKEDA GMBH	Withdrawn by MAH · Not Marketed
DAXAS 500MCG F.C. TABLET	500 µg	Film-coated tablet · Oral use	30 Blister	SAR 128.50	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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

Product	Strength	Form · route	Applicant	Status	First approved
DALIRESP	500MCG; 250MCG	tablet · oral	ASTRAZENECA	Prescription	28 Feb 2011
ROFLUMILAST	500MCG; 250MCG	tablet · oral	SENORES PHARMS	Prescription	3 Oct 2018
ROFLUMILAST	500MCG; 250MCG	tablet · oral	HETERO LABS LTD III	Prescription	23 Nov 2018
ROFLUMILAST	500MCG; 250MCG	tablet · oral	MICRO LABS	Prescription	22 Mar 2019
ROFLUMILAST	500MCG; 250MCG	tablet · oral	STRIDES PHARMA	Prescription	30 Mar 2020
ROFLUMILAST	500MCG; 250MCG	tablet · oral	ZYDUS PHARMS	Prescription	10 Feb 2022
ROFLUMILAST	500MCG	tablet · oral	PRINSTON INC	Prescription	10 May 2022
ZORYVE	0.3%; 0.15%; 0.05%	cream · topical	ARCUTIS	Prescription	29 Jul 2022
ROFLUMILAST	250MCG; 500MCG	tablet · oral	MSN	Prescription	7 Sep 2022
ROFLUMILAST	500MCG; 250MCG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	17 Apr 2023
ROFLUMILAST	250MCG; 500MCG	tablet · oral	ALKEM LABS LTD	Prescription	18 Apr 2023
ZORYVE	0.3%	foam · topical	ARCUTIS	Prescription	15 Dec 2023
ROFLUMILAST	500MCG	tablet · oral	PHARMOBEDIENT	Discontinued	13 Jul 2018
ROFLUMILAST	500MCG; 250MCG	tablet · oral	TORRENT	Discontinued	6 Aug 2018

EMA European Union — centrally authorised medicines

Daxas AstraZeneca AB · Authorised · authorised 5 Jul 2010 · ATC R03DX07

Therapeutic indication (EMA)

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Daliresp AstraZeneca AB · Withdrawn · authorised 28 Feb 2011 · ATC R03DX07

Therapeutic indication (EMA)

Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Libertek AstraZeneca AB · Withdrawn · authorised 28 Feb 2011 · ATC R03DX08

Therapeutic indication (EMA)

Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DAXAS	02359456	500 MCG	TABLET · ORAL	ASTRAZENECA CANADA INC
ZORYVE	02537532	0.3 % / W/W	CREAM · TOPICAL	ARCUTIS CANADA, INC.
ZORYVE	02552566	0.3 % / W/W	FOAM · TOPICAL	ARCUTIS CANADA, INC.
ZORYVE	02556146	0.15 % / W/W	CREAM · TOPICAL	ARCUTIS CANADA, INC.
ZORYVE	02570793	0.05 % / W/W	CREAM · TOPICAL	ARCUTIS CANADA, INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DALIRESP 250 MCG TABLET	$14.98256	per EA	1 Jan 2026
US NADAC	DALIRESP 500 MCG TABLET	$14.9036	per EA	23 Sep 2026
US NADAC	ROFLUMILAST 250 MCG TABLET	$1.98132	per EA	30 Sep 2026
US NADAC	ROFLUMILAST 500 MCG TABLET	$0.31126	per EA	23 Sep 2026
US NADAC	ZORYVE 0.05% CREAM	$15.40606	per GM	23 Sep 2026
US NADAC	ZORYVE 0.15% CREAM	$15.39875	per GM	23 Sep 2026
US NADAC	ZORYVE 0.3% CREAM	$15.38387	per GM	23 Sep 2026
US NADAC	ZORYVE 0.3% FOAM	$15.37781	per GM	23 Sep 2026
NHS Drug Tariff	Roflumilast 250microgram tablets	£35.20	28 tablet	1 Oct 2026
NHS Drug Tariff	Roflumilast 500microgram tablets	£51.10	30 tablet	1 Oct 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 29 Jun 2026 ZORYVE — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 May 2025 ZORYVE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 31 Aug 2017 DALIRESP — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
MHRA 11 Dec 2014 Roflumilast (Daxas▼): risk of suicidal behaviour
Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.

All safety entries for roflumilast →

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.