Is Apremilast registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Apremilast, including Apriva (30 mg, Film-coated tablet, SAR 1998.50); Apriva 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 20 tablets (10-20-30 mg, Film-coated tablet, SAR 932.60); Aprizla (30 mg, Film-coated tablet, SAR 1598.80); Milorizast (30 mg, Film-coated tablet, SAR 1287.45); Milorizast 10 mg - 20 mg - 30 mg starter pack (10-20-30 mg, Film-coated tablet, SAR 539.60).

Is Apremilast approved by the US FDA?

Drugs@FDA lists 17 application product lines for Apremilast, including OTEZLA (Prescription); OTEZLA (Prescription); APREMILAST (Prescription); APREMILAST (Prescription); APREMILAST (Prescription).

Is Apremilast authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Apremilast: Otezla, Apremilast Accord.

Are there safety signals or safety updates for Apremilast?

US FDA: 1 entry; MHRA: 1 entry (latest 2025-12-23).

Active substance

Apremilast

SFDA 9
US FDA 17
EMA 3
Health Canada 10
US price lines 4
NHS prices 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Apriva	30 mg	Film-coated tablet · Oral use	60 Blister	SAR 1998.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Apriva 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 20 tablets	10-20-30 mg	Film-coated tablet · Oral use	28 Blister	SAR 932.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Aprizla	30 mg	Film-coated tablet · Oral use	56 Blister	SAR 1598.80	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Milorizast	30 mg	Film-coated tablet · Oral use	56 Blister	SAR 1287.45	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Milorizast 10 mg - 20 mg - 30 mg starter pack	10-20-30 mg	Film-coated tablet · Oral use	27 Blister	SAR 539.60	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
OTEZLA 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 19 tablets	10-20-30 mg	Film-coated tablet · Oral use	27 Blister	SAR 963.60	NCE · Prescription	Amgen Europe BV	Valid
OTEZLA 30MG F.C.TAB	30 mg	Film-coated tablet · Oral use	56 Blister	SAR 1998.50	NCE · Prescription	Amgen Europe BV	Valid
Wetzo	30 mg	Film-coated tablet · Oral use	56 Blister	SAR 1212.45	Generic · Prescription	Med City Pharma	Valid
Wetzo 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 20 tablets	10-20-30 mg	Film-coated tablet · Oral use	28 Blister	SAR 606.20	Generic · Prescription	Med City Pharma	Valid

Indications — CHI Daman Drug Formulary

PSORIASIS; PSORIATIC ARTHRITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
OTEZLA	10MG; 20MG; 30MG	tablet · oral	AMGEN INC	Prescription	21 Mar 2014
OTEZLA	10MG; 20MG; 30MG	tablet · oral	CELGENE CORP	Prescription	23 Sep 2014
APREMILAST	10MG; 20MG; 30MG	tablet · oral	ALKEM LABS LTD	Prescription	21 Sep 2021
APREMILAST	10MG; 20MG; 30MG	tablet · oral	SHILPA	Prescription	7 Apr 2023
APREMILAST	10MG; 20MG; 30MG	tablet · oral	ANNORA	Prescription	26 Jul 2023
APREMILAST	10MG; 20MG; 30MG	tablet · oral	MANKIND PHARMA	Prescription	7 Feb 2024
APREMILAST	10MG; 20MG; 30MG	tablet · oral	MSN	Prescription	16 Dec 2024
OTEZLA XR	75MG	tablet, extended release · oral	AMGEN INC	Prescription	29 Aug 2025
OTEZLA	10MG; 20MG; 30MG	tablet · oral	AMGEN INC	Prescription	29 Aug 2025
APREMILAST	10MG; 20MG; 30MG	tablet · oral	UNICHEM	Discontinued	17 Feb 2021
APREMILAST	10MG; 20MG; 30MG	tablet · oral	AMNEAL	Discontinued	30 Jun 2021
APREMILAST	10MG; 20MG; 30MG	tablet · oral	TEVA PHARMS USA INC	Discontinued	18 Aug 2022
APREMILAST	10MG; 20MG; 30MG	tablet · oral	DR REDDYS	Discontinued	14 Jul 2023
APREMILAST	10MG; 20MG; 30MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	19 Jul 2023
APREMILAST	10MG; 20MG; 30MG	tablet · oral	GLENMARK PHARMS LTD	Discontinued	16 Oct 2023
APREMILAST	10MG; 20MG; 30MG	tablet · oral	MACLEODS PHARMS	Discontinued	25 Nov 2024
APREMILAST	10MG; 20MG; 30MG	tablet · oral	TORRENT	Discontinued	20 Jun 2025

EMA European Union — centrally authorised medicines

Otezla Amgen Europe B.V. · Authorised · authorised 15 Jan 2015 · ATC L04AA32

Therapeutic indication (EMA)

Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric psoriasisOtezla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.Behçet’s diseaseOtezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.

Apremilast Accord Accord Healthcare S.L.U. · Authorised · authorised 19 Apr 2024 · ATC L04AA32

Therapeutic indication (EMA)

Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).Behçet’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.

Apremilast Viatris Viatris Limited · Application withdrawn · ATC L04AA32

Therapeutic indication (EMA)

Treatment of psoriatic arthritis, psoriasis, Behçet’s disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-APREMILAST	02538180	30 MG	TABLET · ORAL	APOTEX INC
AURO-APREMILAST	02524104	30 MG	TABLET · ORAL	AURO PHARMA INC
AURO-APREMILAST	02524120	30 MG; 20 MG; 10 MG	TABLET · ORAL	AURO PHARMA INC
JAMP APREMILAST	02528959	30 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP APREMILAST	02528967	30 MG; 10 MG; 20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
OTEZLA	02434318	10 MG; 20 MG; 30 MG	TABLET · ORAL	AMGEN CANADA INC
OTEZLA	02434334	30 MG	TABLET · ORAL	AMGEN CANADA INC
PMS-APREMILAST	02521733	30 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ APREMILAST	02529084	30 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ APREMILAST	02529092	30 MG; 10 MG; 20 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OTEZLA 10-20-30 MG START 28 DAY	$98.55082	per EA	23 Sep 2026
US NADAC	OTEZLA 20 MG TABLET	$89.95216	per EA	7 Jan 2026
US NADAC	OTEZLA 30 MG TABLET	$90.57171	per EA	23 Sep 2026
US NADAC	OTEZLA XR 75 MG TABLET	$181.1953	per EA	23 Sep 2026
NHS Drug Tariff	Apremilast 30mg tablets	£550.00	56 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 23 Dec 2025 OTEZLA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 19 Jan 2017 Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Stop treatment if patients have new psychiatric symptoms or if existing symptoms worsen.

All safety entries for apremilast →

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.