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Drug ReportsTobramycin
Tobrex, Tobi podhaler(tobramycin)
Bethkis, Kitabis, Tobi, Tobradex, Tobramycin, Tobrasone, Tobrex, Vantobra, Zylet (tobramycin) is a small molecule pharmaceutical. Tobramycin was first approved as Tobrex on 1982-01-01. It is used to treat bacterial eye infections, bacterial infections, central nervous system infections, infectious bone diseases, and infectious skin diseases amongst others in the USA. It has been approved in Europe to treat cystic fibrosis and respiratory tract infections.
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Novartis Pharmaceuticals
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Bethkis, Kitabis, Tobi, Tobramycin, Tobrex (discontinued: Aktob, Nebcin, Tobramycin, Tobrex)
Combinations
Tobradex, Tobramycin dexamethasone, Zylet (discontinued: Tobramycin dexamethasone, Tobrasone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tobramycin
Tradename
Company
Number
Date
Products
BETHKISChiesi FarmaceuticiN-201820 RX2012-10-12
1 products, RLD, RS
TOBIMylanN-050753 RX1997-12-22
1 products, RLD, RS
TOBI PODHALERMylanN-201688 RX2013-03-22
1 products, RLD, RS
TOBREXNovartisN-050555 RX1982-01-01
1 products, RLD, RS
KITABIS PAKPulmoFlowN-205433 RX2014-12-02
1 products
Show 1 discontinued
Dexamethasone
+
Tobramycin
Tradename
Company
Number
Date
Products
TOBRADEX STHarrowN-050818 RX2009-02-13
1 products, RLD, RS
TOBRADEXNovartisN-050616 RX1988-09-28
1 products, RLD, RS
TOBRADEXSandozN-050592 RX1988-08-18
1 products, RLD, RS
Loteprednol etabonate
+
Tobramycin
Tradename
Company
Number
Date
Products
ZYLETBausch Health CompaniesN-050804 RX2004-12-14
1 products, RLD, RS
Tobramycin sulfate
Tradename
Company
Number
Date
Products
TOBRAMYCIN SULFATEFresenius KabiN-050789 RX2004-07-13
1 products
Show 2 discontinued
Fluorometholone acetate
+
Tobramycin
Tradename
Company
Number
Date
Products
TOBRASONEHarrowN-050628 DISCN1989-07-21
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bethkisNew Drug Application2023-02-24
kitabis pakNew Drug Application2024-11-22
tobiNew Drug Application2023-02-15
tobi podhalerNew Drug Application2023-02-15
tobradexNew Drug Application2024-11-01
tobradex stNew Drug Application2023-10-09
tobramycinANDA2024-12-18
tobramycin and dexamethasoneNDA authorized generic2024-12-31
tobramycin inhalationNDA authorized generic2023-02-24
tobramycin inhalation solutionANDA2024-12-17
Show 3 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract infections—D012141J06.9
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
intraabdominal infections—D059413—
pseudomonas infectionsEFO_0001076D011552A41.52
infectious skin diseases—D012874—
bacterial eye infections—D015818—
staphylococcal infections—D013203A49.01
central nervous system infectionsEFO_1001456D002494A81
infectious bone diseases—D001850—
Show 30 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Tobramycin, Tobi Podhaler, Mylan Speciality Lp
102070662030-11-04DPU-909
88697942028-09-12DPU-909
75593252025-10-27DP
86641872025-06-20U-909
114846712024-11-07DPU-909
RE475262024-04-09DP
75167412024-01-11DP
Dexamethasone / Tobramycin, Tobradex St, Harrow Eye
77953162028-08-03DPU-1082
81015822027-12-19DPU-1082
84502872027-12-19DP
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB01: Tobramycin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA12: Tobramycin
HCPCS
Code
Description
J3260
Injection, tobramycin sulfate, up to 80 mg
J7682
Tobramycin, inhalation solution, fda-approved final product, non-compounded, unit dose form, administered through dme, per 300 milligrams
J7685
Tobramycin, inhalation solution, compounded product, administered through dme, unit dose form, per 300 milligrams
Clinical
Clinical Trials
185 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845———2——2
CataractD002386HP_0000518H26.9——2——2
BlepharitisD001762EFO_0009536H01.0——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dry eye syndromesD015352—H04.121————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTobramycin
INNtobramycin
Description
Tobramycin is a amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. It has a role as an antibacterial agent, an antimicrobial agent and a toxin. It is functionally related to a kanamycin B. It is a conjugate base of a tobramycin(5+).
Classification
Small molecule
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O
Identifiers
PDB—
CAS-ID32986-56-4
RxCUI—
ChEMBL IDCHEMBL1747
ChEBI ID28864
PubChem CID36294
DrugBankDB00684
UNII IDVZ8RRZ51VK (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Tobramycin
+
Dexamethasone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tobramycin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 40,842 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,867 adverse events reported
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