Is Abiraterone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 15 valid registrations of Abiraterone, including ABIRATERONE SPC 250MG F.C.TABLET (250 mg, Film-coated tablet, SAR 6519.15); ABODEX (250 mg, Tablet, SAR 5280.50); ABREMIA 250MG TABLET (250 mg, Tablet, SAR 5867.25); Abetyl (250 mg, Tablet, SAR 5281.00); Abiraterone Acetate Neapolis (250 mg, Tablet, SAR 3996.35).

Is Abiraterone approved by the US FDA?

Drugs@FDA lists 17 application product lines for Abiraterone, including ZYTIGA (Prescription); YONSA (Prescription); ABIRATERONE ACETATE (Prescription); ABIRATERONE ACETATE (Prescription); ABIRATERONE ACETATE (Prescription).

Is Abiraterone authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Abiraterone: Zytiga, Abiraterone Accord, Abiraterone Krka, Abiraterone Mylan.

Is Abiraterone on the WHO Model List of Essential Medicines?

Yes — 8.2.4. Hormones and antihormones (complementary list): Malignant neoplasms of prostate.

Are there safety signals or safety updates for Abiraterone?

EMA PRAC: 4 entries; US FDA: 3 entries (latest 2025-12-12).

Active substance

Abiraterone

SFDA 16
US FDA 17
EMA 4
Health Canada 17
US price lines 2
WHO EML 1
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ABIRATERONE SPC 250MG F.C.TABLET	250 mg	Film-coated tablet · Oral use	120 Bottle	SAR 6519.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
ABODEX	250 mg	Tablet · Oral use	120 Bottle	SAR 5280.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
ABREMIA 250MG TABLET	250 mg	Tablet · Oral use	120 Bottle	SAR 5867.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Abetyl	250 mg	Tablet · Oral use	120 Blister	SAR 5281.00	Generic · Prescription	Abdi Ibrahim Ilac San ve Tic A.S.	Valid
Abiraterone Acetate Neapolis	250 mg	Tablet · Oral use	120 Blister	SAR 3996.35	Generic · Prescription	LES LABORATORIES NEAPOLIS PHARMA	Valid
Abiraterone SPC	500 mg	Film-coated tablet · Oral use	60 Bottle	SAR 5280.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Birato	250 mg	Tablet · Oral use	120 Bottle	SAR 3696.00	Generic · Prescription	Boston Oncology Arabia	Valid
Stamagen	500 mg	Film-coated tablet · Oral use	56 Blister	SAR 3449.90	Generic · Prescription	Med City Pharma	Valid
Tigaron	250 mg	Film-coated tablet · Oral use	120 Blister	SAR 5280.50	Generic · Prescription	SPIMACO	Valid
Tigaron	500 mg	Film-coated tablet · Oral use	60 Blister	SAR 5280.50	Generic · Prescription	SPIMACO	Valid
VELOMAXTO	500 mg	Film-coated tablet · Oral use	60 Bottle	SAR 1041.65	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
VELOMAXTO	250 mg	Tablet · Oral use	120 Bottle	SAR 1041.65	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
ZYTIGA 500 Film-coated Tablet	500 mg	Film-coated tablet · Oral use	60 Bottle	SAR 7522.10	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
abroten	500 mg	Film-coated tablet · Oral use	60 Bottle	SAR 5280.50	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
abroten	250 mg	Film-coated tablet · Oral use	120 Bottle	SAR 5280.50	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
ZYTIGA 250 TABLET	250 mg	Tablet · Oral use	120 Bottle	SAR 10029.45	NCE · Prescription	JANSSEN-CILAG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYTIGA	250MG; 500MG	tablet · oral	JANSSEN BIOTECH	Prescription	28 Apr 2011
YONSA	125MG	tablet · oral	SUN PHARM	Prescription	22 May 2018
ABIRATERONE ACETATE	250MG	tablet · oral	HIKMA	Prescription	31 Oct 2018
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	MYLAN	Prescription	31 Oct 2018
ABIRATERONE ACETATE	250MG	tablet · oral	APOTEX	Prescription	31 Oct 2018
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	AMNEAL PHARMS	Prescription	7 Jan 2019
ABIRATERONE ACETATE	250MG	tablet · oral	RISING	Prescription	25 Feb 2019
ABIRATERONE ACETATE	250MG	tablet · oral	WOCKHARDT BIO AG	Prescription	27 Feb 2019
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	MSN	Prescription	10 Jul 2019
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	QILU	Prescription	27 Sep 2019
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	GLENMARK SPECLT	Prescription	16 Oct 2019
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	DR REDDYS	Prescription	18 May 2020
ABIRATERONE ACETATE	250MG; 500MG	tablet · oral	NOVUGEN	Prescription	5 Jan 2022
ABIRATERONE ACETATE	500MG	tablet · oral	REGCON HOLDINGS	Prescription	23 Mar 2023
ABIRATERONE ACETATE	250MG	tablet · oral	TEVA PHARMS USA	Discontinued	31 Oct 2018
ABIRATERONE ACETATE	125MG	tablet · oral	TEVA PHARMS USA	Discontinued	24 Jun 2022
ABIRATERONE ACETATE	500MG	tablet · oral	TEVA PHARMS USA	Discontinued	26 Jan 2023

EMA European Union — centrally authorised medicines

Zytiga Janssen-Cilag International · Authorised · authorised 5 Sep 2011 · ATC L02BX03

Therapeutic indication (EMA)

Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Abiraterone Accord Accord Healthcare S.L.U. · Authorised · authorised 26 Apr 2021 · ATC L02BX03

Therapeutic indication (EMA)

Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Abiraterone Krka Krka, d.d., Novo mesto · Authorised · authorised 24 Jun 2021 · ATC L02BX03

Therapeutic indication (EMA)

Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Abiraterone Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 20 Aug 2021 · ATC L02BX03

Therapeutic indication (EMA)

Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ABIRATERONE FILM COATED TABLETS	02491397	250 MG	TABLET · ORAL	APOTEX INC
APO-ABIRATERONE FILM COATED TABLETS	02491400	500 MG	TABLET · ORAL	APOTEX INC
JAMP ABIRATERONE	02502305	250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP ABIRATERONE	02529629	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MAR-ABIRATERONE	02503980	250 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-ABIRATERONE	02503999	500 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
NAT-ABIRATERONE	02494132	250 MG	TABLET · ORAL	NATCO PHARMA (CANADA) INC
PMS-ABIRATERONE	02492601	250 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-ABIRATERONE	02501503	500 MG	TABLET · ORAL	PHARMASCIENCE INC
PRZ-ABIRATERONE	02540452	250 MG	TABLET · ORAL	PHARMARIS CANADA INC
PRZ-ABIRATERONE	02540460	500 MG	TABLET · ORAL	PHARMARIS CANADA INC
REDDY-ABIRATERONE	02477114	250 MG	TABLET · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-ABIRATERONE	02533251	500 MG	TABLET · ORAL	DR REDDY'S LABORATORIES LTD
SANDOZ ABIRATERONE	02486393	250 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ ABIRATERONE	02521644	500 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
ZYTIGA	02371065	250 MG	TABLET · ORAL	JANSSEN INC
ZYTIGA	02457113	500 MG	TABLET · ORAL	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ABIRATERONE ACETATE 250 MG TAB	$0.77414	per EA	23 Sep 2026
US NADAC	ABIRATERONE ACETATE 500 MG TAB	$2.59443	per EA	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.

WHO WHO Model List of Essential Medicines (2025)

8.2.4. Hormones and antihormones · complementary
Malignant neoplasms of prostate
Oral > Solid: 250 mg; 500 mg

Safety signals and safety-related labeling changes

US FDA 12 Dec 2025 AKEEGA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Mar 2022 YONSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Aug 2021 ZYTIGA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 3 Sep 2020 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: Yes
EMA PRAC 17 Apr 2020 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Interaction with sulphonylureas leading to hypoglycaemia
Action for MAH: update of the product information: Yes
EMA PRAC 5 Sep 2019 PRAC signal: Interaction with sulphonylureas leading to hypoglycaemia
Action for MAH: update of the product information: No

All safety entries for abiraterone →

Combinations containing Abiraterone

Abiraterone + niraparib

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.