Is Tobramycin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Tobramycin, including TOBI PODHALER 28MG (28 mg, Inhalation powder, hard capsule, SAR 11890.70); TOBRACIN 0.3% EYE DROPS (0.3 %, Eye drops, SAR 11.35); TOBRACIN 0.3% EYE OINTMENT (0.3 %, Eye ointment, SAR 10.65); TOBREX OPTH.OINT. 0.3% (0.3 %, Eye ointment, SAR 18.70); TOBREX OPTH.SOLUTION 0.3% (0.3 %, Eye drops, solution, SAR 20.00).

Is Tobramycin approved by the US FDA?

Drugs@FDA lists 64 application product lines for Tobramycin, including TOBREX (Prescription); TOBREX (Prescription); TOBRAMYCIN SULFATE (Prescription); TOBRAMYCIN SULFATE (Prescription); TOBRAMYCIN (Prescription).

Is Tobramycin authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Tobramycin: Tobi Podhaler, Vantobra (previously Tobramycin PARI).

Is Tobramycin on the WHO Model List of Essential Medicines?

Yes — 21.1. Ophthalmological preparations > Anti-infective agents (core list): Therapeutic equivalent to gentamicin for Other specified conjunctivitis; Therapeutic equivalent to gentamicin for Infectious blepharitis.

Are there safety signals or safety updates for Tobramycin?

US FDA: 11 entries (latest 2026-03-17).

Active substance

Tobramycin

SFDA 10
US FDA 64
EMA 3
Health Canada 12
US price lines 4
NHS prices 6
WHO EML 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TOBI PODHALER 28MG	28 mg	Inhalation powder, hard capsule · Inhalation use	4 Inhaler	SAR 11890.70	NCE · Prescription	Mylan Pharma GmbH	Valid
TOBRACIN 0.3% EYE DROPS	0.3 %	Eye drops · Ophthalmic use	1 Dropper Container	SAR 11.35	Generic · Prescription	Amman Pharmaceutical Industries (API)	Valid
TOBRACIN 0.3% EYE OINTMENT	0.3 %	Eye ointment · Ophthalmic use	1 Tube	SAR 10.65	Generic · Prescription	Amman Pharmaceutical Industries (API)	Valid
TOBREX OPTH.OINT. 0.3%	0.3 %	Eye ointment · Ocular use	1 Tube	SAR 18.70	NCE · Prescription	NOVARTIS PHARMA AG	Valid
TOBREX OPTH.SOLUTION 0.3%	0.3 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 20.00	NCE · Prescription	NOVARTIS PHARMA AG	Valid
Tofibra	300 mg	Nebuliser solution · Inhalation use	56 Ampoule	SAR 9762.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NEBCIN 20MG-2ML VIAL	10 mg/ml	Injection · Parenteral use	1 Vial	SAR 9.50	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
NEBCIN 80MG-2ML VIAL	40 mg/ml	Injection · Parenteral use	1 Vial	SAR 19.15	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
TOBI PODHALER 28MG	28 mg	Inhalation powder, hard capsule · Inhalation use	4 Inhaler	SAR 11890.70	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
TOBRAMYCIN 20MG-2ML VIAL	10 mg/ml	Solution · Parenteral use	5 Ampoule	SAR 38.90	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS)-LONG-TERM ORAL ANTIBIOTIC TREATMENT; CYSTIC FIBROSIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; OSTEOMYELITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TOBREX	0.3%	ointment · ophthalmic	NOVARTIS	Prescription	25 Nov 1981
TOBREX	0.3%	solution/drops · ophthalmic	SANDOZ	Prescription	13 Dec 1984
TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	26 Apr 1991
TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	injectable · injection	HOSPIRA	Prescription	30 Apr 1991
TOBRAMYCIN	0.3%	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	29 Nov 1993
TOBI	300MG/5ML	solution · inhalation	VIATRIS	Prescription	22 Dec 1997
TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	injectable · injection	XGEN PHARMS	Prescription	17 Aug 2001
TOBRAMYCIN	0.3%	solution/drops · ophthalmic	CHARTWELL RX	Prescription	11 Sep 2001
TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	29 Nov 2002
TOBRAMYCIN SULFATE	EQ 10MG BASE/ML; EQ 40MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	29 Nov 2002
TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	13 Jul 2004
TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	injectable · injection	MYLAN LABS LTD	Prescription	11 Mar 2008
BETHKIS	300MG/4ML	solution · inhalation	CHIESI	Prescription	12 Oct 2012
TOBI PODHALER	28MG	powder · inhalation	VIATRIS	Prescription	22 Mar 2013
TOBRAMYCIN	300MG/5ML	solution · inhalation	TEVA PHARMS USA	Prescription	10 Oct 2013
TOBRAMYCIN	300MG/5ML	solution · inhalation	HIKMA PHARMS	Prescription	28 May 2014
TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	injectable · injection	XELLIA PHARMS APS	Prescription	16 Sep 2014
KITABIS PAK	300MG/5ML	solution · inhalation	PULMOFLOW INC	Prescription	2 Dec 2014
TOBRAMYCIN	300MG/5ML	solution · inhalation	AMNEAL PHARMS	Prescription	13 Jul 2015
TOBRAMYCIN	300MG/5ML	solution · inhalation	LUPIN	Prescription	22 Mar 2017
TOBRAMYCIN	0.3%	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	28 Jun 2017
TOBRAMYCIN	300MG/5ML	solution · inhalation	DR REDDYS LABS SA	Prescription	9 Jul 2018
TOBRAMYCIN	0.3%	solution/drops · ophthalmic	ALEMBIC	Prescription	19 Apr 2019
TOBRAMYCIN	300MG/5ML	solution · inhalation	SUN PHARM	Prescription	26 Dec 2019
TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	injectable · injection	GLAND	Prescription	9 Feb 2021

39 more — full table

EMA European Union — centrally authorised medicines

Tobi Podhaler Viatris Healthcare Limited · Authorised · authorised 20 Jul 2011 · ATC J01GB01

Therapeutic indication (EMA)

Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Vantobra (previously Tobramycin PARI) Pari Pharma GmbH · Authorised · authorised 18 Feb 2019 · ATC J01GB01

Therapeutic indication (EMA)

Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Vantobra Pari Pharma GmbH · Withdrawn · authorised 18 Mar 2015 · ATC J01GB01

Therapeutic indication (EMA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SANDOZ TOBRAMYCIN	02241755	0.3 %	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED
TEVA-TOBRAMYCIN	02389622	60 MG / ML	SOLUTION · INHALATION	TEVA CANADA LIMITED
TOBI	02239630	300 MG / 5 ML	SOLUTION · INHALATION	BGP PHARMA ULC
TOBI PODHALER	02365154	28 MG	CAPSULE · INHALATION	BGP PHARMA ULC
TOBRAMYCIN FOR INJECTION	00533688	1.2 G / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
TOBRAMYCIN INJECTION USP	02241209	10 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
TOBRAMYCIN INJECTION USP	02241210	40 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
TOBRAMYCIN INJECTION USP	02502372	40 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	STERIMAX INC
TOBRAMYCIN INJECTION USP	02533103	40 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	JAMP PHARMA CORPORATION
TOBRAMYCIN INJECTION, USP	02230640	40 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	FRESENIUS KABI CANADA LTD
TOBREX	00513962	0.3 % / W/V	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
TOBREX	00614254	0.3 % / W/W	OINTMENT · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TOBRAMYCIN 0.3% EYE DROP	$1.1081	per ML	23 Sep 2026
US NADAC	TOBRAMYCIN 300 MG/5 ML AMPULE	$1.084	per ML	23 Sep 2026
US NADAC	TOBRAMYCIN 80 MG/2 ML VIAL	$0.83153	per ML	23 Sep 2026
US NADAC	TOBREX 0.3% EYE OINTMENT	$84.41452	per GM	23 Sep 2026
NHS Drug Tariff	Tobramycin 240mg/6ml solution for injection vials	£19.20	1 vial	1 Oct 2026
NHS Drug Tariff	Tobramycin 28mg inhalation powder capsules with device	£1790.00	224 capsule	1 Oct 2026
NHS Drug Tariff	Tobramycin 300mg/4ml nebuliser liquid ampoules	£1187.00	56 ampoule	1 Oct 2026
NHS Drug Tariff	Tobramycin 300mg/5ml nebuliser liquid ampoules	£1187.00	56 ampoule	1 Oct 2026
NHS Drug Tariff	Tobramycin 80mg/2ml solution for injection vials	£5.37	1 vial	1 Oct 2026
NHS Drug Tariff	Tobramycin 80mg/2ml solution for injection vials	£20.80	5 vial	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)

21.1. Ophthalmological preparations > Anti-infective agents · core
Therapeutic equivalent to gentamicin for Other specified conjunctivitis; Therapeutic equivalent to gentamicin for Infectious blepharitis

Safety signals and safety-related labeling changes

US FDA 17 Mar 2026 TOBRADEX ST — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Apr 2023 KITABIS PAK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Feb 2023 BETHKIS — 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 10 Feb 2023 TOBI — 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 10 Feb 2023 TOBI PODHALER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Feb 2023 TOBRAMYCIN SULFATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Oct 2021 ZYLET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 TOBRADEX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions
US FDA 14 May 2021 TOBRADEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 14 May 2021 TOBREX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 14 May 2021 TOBREX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for tobramycin →

Combinations containing Tobramycin

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.