Is Ketotifen registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Ketotifen, including ASMAFORT 1MGTAB (1 mg, Tablet, SAR 15.60); ASMAFORT 1MG\5ML SYRUP (0.2 mg/ml, Syrup, SAR 20.40); Fenobat (0.2 mg/ml, Syrup, SAR 24.40); HISTOFEN SYRUP 1MG/5ML (0.2 mg/ml, Eye drops, SAR 22.65); KETONIL 1MG-5ML SYRUP (0.2 mg/ml, Syrup, SAR 22.70).

Is Ketotifen approved by the US FDA?

Drugs@FDA lists 9 application product lines for Ketotifen, including ALAWAY (Over-the-counter); CHILDREN'S ALAWAY (Over-the-counter); KETOTIFEN FUMARATE (Over-the-counter); ZADITOR (Over-the-counter); KETOTIFEN FUMARATE (Over-the-counter).

Active substance

Ketotifen

SFDA 19
US FDA 9
Health Canada 3
US price lines 3
NHS prices 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ASMAFORT 1MGTAB	1 mg	Tablet · Oral use	20 Blister	SAR 15.60	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
ASMAFORT 1MG\5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 20.40	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
Fenobat	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 24.40	Generic · OTC	BATTERJEE PHARMACETICAL FACTORY	Valid
HISTOFEN SYRUP 1MG/5ML	0.2 mg/ml	Eye drops · Ocular use	1 Bottle	SAR 22.65	Generic · OTC	RIYADH PHARMA	Valid
KETONIL 1MG-5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 22.70	Generic · OTC	Ram Pharmaceutical Industries	Valid
Keta	0.025 %	Eye drops · Ophthalmic use	1 Bottle	SAR 21.50	Generic · OTC	Amman Pharmaceutical Industries (API)	Valid
PROFILAR 1MG/5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 18.30	Generic · OTC	UNITED PHARMACEUTICAL CO.	Valid
GLODITEN 1MG TABLETS	1 mg	Tablet · Oral use	30 Blister	SAR 16.95	Generic · Prescription	GLOBAL PHARMA	Withdrawn by MAH · Not Marketed
GLODITEN 1MG\5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 18.35	Generic · OTC	GLOBAL PHARMA	Withdrawn by MAH · Not Marketed
HISTOFEN	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 21.45	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
KETOFEN 1MG TAB	1 mg	Tablet · Oral use	30 Blister	SAR 26.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
KETOFEN 1MG-5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 25.20	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
TEFANYL 1 MG TABLETS	1 mg	Tablet · Oral use	30 Blister	SAR 18.10	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
TEFANYL 1MG\5ML SYRUP	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 20.30	Generic · OTC	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
TOTINAL SYRUP 1MG-5ML	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 25.90	NCE · OTC	Hikma Pharmaceuticals PLC	Withdrawn by MAH · Not Marketed
ZADITEN 0.25 MG - ML SINGLE DOSE UNIT	0.25 mg/ml	Eye drops · Ocular use	20 Single Dose Container	SAR 45.25	NCE · OTC	NOVARTIS	Withdrawn by MAH · Not Marketed
ZADITEN 0.25 MG-ML EYE DROPS	0.25 mg/ml	Eye drops · Ocular use	1 Dropper Container	SAR 28.30	NCE · OTC	NOVARTIS	Withdrawn by MAH · Not Marketed
ZADITEN SYRUP 1MG-5ML	0.2 mg/ml	Syrup · Oral use	1 Bottle	SAR 29.55	NCE · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
ZADITEN TAB 1MG	1 mg	Tablet · Oral use	30 Blister	SAR 28.90	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); HUMAN IMMUNODEFICIENCY VIRUS; TUBERCULOSIS-SUPPORTIVE CARE

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

Product	Strength	Form · route	Applicant	Status	First approved
ALAWAY	EQ 0.025% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB	Over-the-counter	1 Dec 2006
CHILDREN'S ALAWAY	EQ 0.025% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB	Over-the-counter	1 Dec 2006
KETOTIFEN FUMARATE	EQ 0.025% BASE	solution/drops · ophthalmic	SENTISS	Over-the-counter	26 Jul 2007
ZADITOR	EQ 0.025% BASE	solution/drops · ophthalmic	ALCON PHARMS LTD	Over-the-counter	2 Sep 2008
KETOTIFEN FUMARATE	EQ 0.025% BASE	solution/drops · ophthalmic	UNICHEM	Over-the-counter	1 Jun 2020
ZADITOR	EQ 0.025% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution/drops · ophthalmic	ALCON PHARMA	Discontinued	2 Jul 1999
KETOTIFEN FUMARATE	EQ 0.025% BASE	solution/drops · ophthalmic	APOTEX INC	Discontinued	9 May 2006
ALAWAY	EQ 0.025% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Discontinued	24 Sep 2020
ACUVUE THERAVISION WITH KETOTIFEN	EQ 19MCG BASE	drug-eluting contact lens · ophthalmic	JOHNSON JOHNSON VISN	Discontinued	25 Feb 2022

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP KETOTIFEN OPHTHALMIC	02542722	0.25 MG / ML	SOLUTION · OPHTHALMIC	JAMP PHARMA CORPORATION
ZADITEN	00577308	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
ZADITOR	02242324	0.25 MG / ML	SOLUTION · OPHTHALMIC	LABORATOIRES THEA

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KETOTIFEN 0.025% (0.035%) DROP	$1.29403	per ML	23 Sep 2026
US NADAC	ZADITOR 0.025% (0.035%) DROPS	$2.22853	per ML	23 Sep 2026
US NADAC	ZADITOR 0.025% (0.035%) DROPS	$1.87003	per ML	23 Sep 2026
NHS Drug Tariff	Ketotifen 1mg tablets	£19.95	60 tablet	1 Oct 2026
NHS Drug Tariff	Ketotifen 1mg/5ml oral solution sugar free	£22.45	300 ml	1 Oct 2026
NHS Drug Tariff	Ketotifen 250micrograms/ml eye drops	£7.80	5 ml	1 Oct 2026
NHS Drug Tariff	Ketotifen 250micrograms/ml eye drops 0.4ml unit dose preservative free	£6.95	30 unit dose	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.

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.