Tobramycin

Treats external infections of the eye and its adnexa caused by susceptible bacteria. Sold as Tobrex, Tobi, Tobi Podhaler, Bethkis, Kitabis Pak. Every FDA application for this active ingredient: 6 branded and 22 generic.

As of Nov 14, 2026, FDA lists 28 applications for Tobramycin (sold as Tobrex, Tobi, Tobi Podhaler and others), first approved Dec 12, 1980, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 12, 1980
Applications: 28
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $30.8M
First approved in the EU: Jul 20, 2011

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Tobi Podhaler	Part D	$12.8M	+10%	374
Bethkis	Part B	$9.6M	-5%	3,827
Tobramycin Sulfate	Part D	$6.9M	-6%	4,976
Tobrex	Part D	$1.4M	+9%	3,760
Tobramycin Sulfate	Part B	$62K	-9%	6,112

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TOBRAMYCIN 0.3% EYE DROP: $1.10 per MLGeneric · +7% in a year
TOBRAMYCIN 300 MG/5 ML AMPULE: $1.05 per MLGeneric · -21% in a year
TOBRAMYCIN 80 MG/2 ML VIAL: $0.928 per MLGeneric · +14% in a year
TOBREX 0.3% EYE OINTMENT: $84.33 per GMBrand · +10% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of bronchiectasis patients infected with Pseudomonas aeruginosa.Novartis Pharmaceuticals Corp. · designated Jun 18, 1999

Approvals in the EU (EMA)

First approved in the EU 367 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Vantobra (previously Tobramycin PARI)Pari Pharma GmbH · Feb 18, 2019
VantobraPari Pharma GmbH · Mar 18, 2015 · withdrawn
Tobi Podhaler, new substanceViatris Healthcare Limited · Jul 20, 2011

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Tobi, new approvalA drug with a new route of administration indicated for the improvement of symptoms associated with respiratory infection caused by Pseudomonas aeruginosa… · Novartis Pharma K.K. · Sep 28, 2012

Clinical Trials

16 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of InfectionTibial Fractures, Fractures, Open · Reselute, Inc.	Not applicable	Not yet recruiting	Nov 10, 2026
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated PneumoniaPneumonia, Ventilator-Associated · Second Affiliated Hospital, Zhejiang University, School of Medicine	Phase 4	Not yet recruiting	Oct 2, 2026
Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Controlled TrialCritical Illness, Mechanical Ventilation · University of Calgary	Phase 2	Not yet recruiting	Mar 11, 2026
Local Antibiotic Concentrations With Tissue Expanders in Breast ReconstructionTissue Expander Based Breast Reconstruction · University of California, Davis	Not applicable	Not yet recruiting	Jan 14, 2026
Fluorometholone StudyKeratitis Bacterial, Corneal Ulcer (Diagnosis) · Vishal Jhanji	Phase 2	Not yet recruiting	Dec 30, 2025
Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of CareFebrile Urinary Tract Infection · Uppsala University	Phase 4	Recruiting	Nov 19, 2025
Antibiotic Impregnated Beads in OsteomyelitisOsteomyelitis of the Foot, Antibiotic Impregnated Beads · University of Arizona	Phase 4	Not yet recruiting	Jul 18, 2025
Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)Bronchiectasis Adult · Shanghai Pulmonary Hospital, Shanghai, China	—	Recruiting	Jan 6, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 12, 1980	TobrexNDA 50541 · New dosage form	Novartis	21	Discontinued
Nov 25, 1981	TobrexNDA 50555 · New dosage form	Novartis	16	Marketed
Dec 13, 1984	TobrexANDA 62535	Sandoz	22	Marketed
Nov 29, 1993	TobramycinANDA 64052	Bausch And Lomb Inc	21	Marketed
May 25, 1994	TobramycinANDA 63176	Alcon Pharms Ltd	4	Discontinued
Jan 31, 1996	AktobANDA 64096	Epic Pharma LLC	6	Discontinued
Dec 22, 1997	TobiNDA 50753 · New dosage form	Viatris	15	Marketed
Sep 11, 2001	TobramycinANDA 65026	Chartwell Rx	0	Marketed
Feb 25, 2002	TobramycinANDA 65087	Apotex Inc	0	Discontinued
Oct 12, 2012	BethkisNDA 201820 · New formulation or manufacturer	Chiesi	4	Marketed
Mar 22, 2013	Tobi PodhalerNDA 201688 · New dosage form	Viatris	11	Marketed
Oct 10, 2013	TobramycinANDA 91589	Teva Pharms USA	6	Marketed
May 28, 2014	TobramycinANDA 201422	Hikma	4	Marketed
Dec 2, 2014	Kitabis PakNDA 205433 · New formulation or manufacturer	Pulmoflow Inc	4	Marketed
Jul 13, 2015	TobramycinANDA 205501	Amneal Pharms	2	Marketed
Mar 22, 2017	TobramycinANDA 208964	Lupin	2	Marketed
Jun 28, 2017	TobramycinANDA 207444	Somerset Theraps LLC	3	Marketed
Oct 13, 2017	TobramycinANDA 209554	Pharmobedient	1	Discontinued
Jul 9, 2018	TobramycinANDA 207080	Dr Reddys Labs SA	2	Marketed
Apr 19, 2019	TobramycinANDA 211847	Alembic	2	Marketed
Jun 26, 2019	TobramycinANDA 210915	Teva Pharms USA	1	Discontinued
Dec 26, 2019	TobramycinANDA 207136	Sun Pharm	2	Marketed
Jan 22, 2021	TobramycinANDA 210871	Luoxin Aurovitas	1	Discontinued
Mar 9, 2021	TobramycinANDA 212628	Gland	1	Marketed
Apr 1, 2021	TobramycinANDA 212848	Alkem Labs Ltd	1	Marketed
Sep 22, 2022	TobramycinANDA 216725	Mankind Pharma	1	Marketed
Jun 30, 2023	TobramycinANDA 214478	Mankind Pharma	0	Marketed
Jul 27, 2023	TobramycinANDA 217344	Micro Labs	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA