Is Bicalutamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Bicalutamide, including BICAPROS (50 mg, Film-coated tablet, SAR 218.20); Bicalutamide Pharmacare (50 mg, Film-coated tablet, SAR 142.25); CLAMUDEX (50 mg, Film-coated tablet, SAR 230.00).

Is Bicalutamide approved by the US FDA?

Drugs@FDA lists 15 application product lines for Bicalutamide, including CASODEX (Prescription); CASODEX (Prescription); BICALUTAMIDE (Prescription); BICALUTAMIDE (Prescription); BICALUTAMIDE (Prescription).

Is Bicalutamide 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 Bicalutamide?

US FDA: 1 entry (latest 2017-03-17).

Active substance

Bicalutamide

SFDA 4
US FDA 15
Health Canada 6
US price lines 1
NHS prices 2
WHO EML 1
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
BICAPROS	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 218.20	Generic · Prescription	Eva Pharma for Pharmaceuticals & Medical Appliances	Valid
Bicalutamide Pharmacare	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 142.25	Generic · Prescription	Pharmacare Premium Ltd	Valid
CLAMUDEX	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 230.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Bicalutamide Pharmacare	150	Film-coated tablet · Oral use	30 Blister	SAR 261.80	Generic · Prescription	Pharmacare Premium Ltd	Suspended · 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
CASODEX	50MG	tablet · oral	ANI PHARMS	Prescription	4 Oct 1995
CASODEX	50MG	tablet · oral	ASTRAZENECA	Prescription	19 Dec 2008
BICALUTAMIDE	50MG	tablet · oral	SANDOZ	Prescription	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	ACCORD HLTHCARE	Prescription	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	ADAPTIS	Prescription	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	SUN PHARM	Prescription	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	WATSON LABS TEVA	Prescription	28 Aug 2009
BICALUTAMIDE	50MG	tablet · oral	CHARTWELL RX	Prescription	10 Jun 2015
BICALUTAMIDE	50MG	tablet · oral	TEVA	Discontinued	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	SYNTHON PHARMS	Discontinued	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	KUDCO IRELAND	Discontinued	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	RISING	Discontinued	6 Jul 2009
BICALUTAMIDE	50MG	tablet · oral	FRESENIUS KABI USA	Discontinued	13 May 2010
BICALUTAMIDE	50MG	tablet · oral	ROXANE	Discontinued	24 Mar 2011
BICALUTAMIDE	50MG	tablet · oral	APOTEX	Discontinued	21 May 2015

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-BICALUTAMIDE	02325985	50 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
BICALUTAMIDE	02519178	50 MG	TABLET · ORAL	SANIS HEALTH INC
JAMP BICALUTAMIDE	02357216	50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
PMS-BICALUTAMIDE	02275589	50 MG	TABLET · ORAL	PHARMASCIENCE INC
PRO-BICALUTAMIDE	02311038	50 MG	TABLET · ORAL	PRO DOC LIMITEE
TEVA-BICALUTAMIDE	02270226	50 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BICALUTAMIDE 50 MG TABLET	$0.40441	per EA	23 Sep 2026
NHS Drug Tariff	Bicalutamide 150mg tablets	£3.57	28 tablet	1 Oct 2026
NHS Drug Tariff	Bicalutamide 50mg tablets	£2.27	28 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.

WHO WHO Model List of Essential Medicines (2025)

8.2.4. Hormones and antihormones · complementary
Malignant neoplasms of prostate
Oral > Solid: 50 mg

Safety signals and safety-related labeling changes

US FDA 17 Mar 2017 CASODEX — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bicalutamide →

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.