Is Exemestane registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Exemestane, including AREKSA 25MG F.C.TAB (25 mg, Film-coated tablet, SAR 79.95); AROMAPLEX 25 mg Film-Coated Tablet (25 mg, Film-coated tablet, SAR 95.40); AROMASIN 25MG COATED TAB (25 mg, Coated tablet, SAR 303.10); EZOLOC 25 MG TABLET (25 mg, Film-coated tablet, SAR 98.70); XEMETAN 25MG F.C.TABLET (25 mg, Coated tablet, SAR 88.85).

Is Exemestane approved by the US FDA?

Drugs@FDA lists 12 application product lines for Exemestane, including AROMASIN (Prescription); EXEMESTANE (Prescription); EXEMESTANE (Prescription); EXEMESTANE (Prescription); EXEMESTANE (Prescription).

Are there safety signals or safety updates for Exemestane?

US FDA: 1 entry (latest 2024-12-16).

Active substance

Exemestane

SFDA 6
US FDA 12
Health Canada 3
US price lines 2
NHS prices 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
AREKSA 25MG F.C.TAB	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 79.95	Generic · Prescription	Accord Healthcare Limited	Valid
AROMAPLEX 25 mg Film-Coated Tablet	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 95.40	Generic · Prescription	GENEPHARM S.A	Valid
AROMASIN 25MG COATED TAB	25 mg	Coated tablet · Oral use	30 Blister	SAR 303.10	NCE · Prescription	PFIZER	Valid
EZOLOC 25 MG TABLET	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.70	Generic · Prescription	SPIMACO ADDWAEIH	Valid
XEMETAN 25MG F.C.TABLET	25 mg	Coated tablet · Oral use	30 Blister	SAR 88.85	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
EZOLOC 25 MG TABLET	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.70	Generic · Prescription	EirGen Pharma	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BREAST CANCER EARLY HORMONAL; BREAST CANCER MET.HORMONAL; ENDOMETRIOSIS; OVARIAN CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
AROMASIN	25MG	tablet · oral	PFIZER	Prescription	21 Oct 1999
EXEMESTANE	25MG	tablet · oral	RISING	Prescription	10 Mar 2017
EXEMESTANE	25MG	tablet · oral	UPSHER SMITH LABS	Prescription	26 Jul 2017
EXEMESTANE	25MG	tablet · oral	CIPLA	Prescription	27 Apr 2018
EXEMESTANE	25MG	tablet · oral	ZYDUS PHARMS	Prescription	3 Oct 2018
EXEMESTANE	25MG	tablet · oral	BRECKENRIDGE	Prescription	21 Feb 2019
EXEMESTANE	25MG	tablet · oral	QILU	Prescription	13 Apr 2020
EXEMESTANE	25MG	tablet · oral	EUGIA PHARMA	Prescription	20 May 2022
EXEMESTANE	25MG	tablet · oral	HIKMA PHARMS	Discontinued	1 Apr 2011
EXEMESTANE	25MG	tablet · oral	EIRGEN	Discontinued	28 Jul 2014
EXEMESTANE	25MG	tablet · oral	AMNEAL PHARMS	Discontinued	28 Dec 2018
EXEMESTANE	25MG	tablet · oral	DR REDDYS LABS SA	Discontinued	8 Aug 2019

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACT EXEMESTANE	02390183	25 MG	TABLET · ORAL	TEVA CANADA LIMITED
AROMASIN	02242705	25 MG	TABLET · ORAL	PFIZER CANADA ULC
MED-EXEMESTANE	02407841	25 MG	TABLET · ORAL	GENERIC MEDICAL PARTNERS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AROMASIN 25 MG TABLET	$38.97921	per EA	1 Jan 2026
US NADAC	EXEMESTANE 25 MG TABLET	$0.74782	per EA	23 Sep 2026
NHS Drug Tariff	Exemestane 25mg tablets	£4.27	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 16 Dec 2024 AROMASIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for exemestane →

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.