Is Diflunisal registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Diflunisal.

Is Diflunisal approved by the US FDA?

Drugs@FDA lists 10 application product lines for Diflunisal, including DIFLUNISAL (Prescription); DIFLUNISAL (Prescription); DIFLUNISAL (Prescription); DOLOBID (Discontinued); DIFLUNISAL (Discontinued).

Is Diflunisal authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Diflunisal: Attrogy.

Active substance

Diflunisal

SFDA 4
US FDA 10
EMA 1
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DOLOBID	500 mg	Tablet · Oral use	20 Blister	SAR 24.10	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
DOLOBID	500 mg	Tablet · Oral use	10 Blister	SAR 17.10	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
DOLOBID	250 mg	Tablet · Oral use	50 Blister	SAR 29.20	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
DOLOBID	250 mg	Tablet · Oral use	20 Blister	SAR 17.10	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
DIFLUNISAL	500MG	tablet · oral	TEVA	Prescription	31 Jul 1992
DIFLUNISAL	500MG; 250MG; 375MG	tablet · oral	HERITAGE PHARMA	Prescription	8 Mar 2012
DIFLUNISAL	500MG	tablet · oral	ZYDUS PHARMS	Prescription	16 Jun 2017
DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	MERCK	Discontinued	19 Apr 1982
DIFLUNISAL	250MG	tablet · oral	TEVA	Discontinued	31 Jul 1992
DIFLUNISAL	250MG	tablet · oral	DASTECH INTL	Discontinued	27 Nov 1992
DIFLUNISAL	500MG	tablet · oral	DASTECH INTL	Discontinued	27 Nov 1992
DIFLUNISAL	250MG; 500MG	tablet · oral	PUREPAC PHARM	Discontinued	7 May 1996
DIFLUNISAL	500MG	tablet · oral	ANI PHARMS	Discontinued	10 Jun 1996
DIFLUNISAL	250MG; 500MG	tablet · oral	WATSON LABS	Discontinued	17 Jul 1997

EMA European Union — centrally authorised medicines

Attrogy Purpose Pharma International AB · Authorised · authorised 17 Jul 2025 · ATC N02BA11

Therapeutic indication (EMA)

Attrogy is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DIFLUNISAL 500 MG TABLET	$1.06451	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.

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.