Skip to main content

tobramycin

Generic: TOBRAMYCIN SULFATE·Brand: AKTOB, BETHKIS, KITABIS PAK, NEBCIN, TOBI, TOBI PODHALER, TOBRAMYCIN, TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBREX

tobramycin: sourced relationships with 1 company · 1 clinical trial tracked · 1 FDA decision.

tobramycin evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect tobramycin to VTRS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could tobramycin → VTRS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Surgical Site Infection

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Viatris Inc (VTRS)
Reported 2013-03-22 · Current development: unknownSource
Approved
Clinical Trial Registry Records (1)

Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

NCT04964947Registry updated 2026-09-16·Phase 3
Completed

Primary endpoint: Rate of infection

InterventionalRandomizedopen600 enrolledStarted 2022-01Completion 2026-073 sites · United StatesMassachusetts General Hospital
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE TOBI Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ] . TOBI Podhaler is an aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80%, or patients colonized with Burkholderia cepacia ( 1 )(VTRS)FDA ↗
NDA201688Type 3 - New Dosage FormOrphan DrugStandardInhalationPowder

Frequently asked questions

Which companies have sourced relationships with tobramycin?

tobramycin has dated SEC/FDA relationship records for Viatris Inc.

How many clinical trials involve tobramycin?

BioSniper tracks 1 clinical trial involving tobramycin.

What is tobramycin's latest FDA decision?

The most recent tracked FDA decision for tobramycin is Approval for 1 INDICATIONS AND USAGE TOBI Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ] . TOBI Podhaler is an aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80%, or patients colonized with Burkholderia cepacia ( 1 ), dated March 22, 2013.