Tobramycin
As of the edition of 20 October 2026, Tobramycin is a small molecule: marketed, first approved in 1981 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Nebcin
- First approved
- 31 December 1981 (CA)
- Approvals on record
- 26 in 7 regions
- Holder of the most recent approval
- VIATRIS FARMACEUTICA DO BRASIL LTDA; 16 holders in all
- Withdrawn from market
- 18 February 2019 (in some regions)
- Registered trials
- 70, 8 stopped early
- Disease areas
- Lungs and airways; Inherited and neonatal; Digestive system; Infections; Eye; Injuries
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 9 | 1 | 2 |
| Phase 1 | 10 | 9 | 0 | 0 |
| Phase 2 | 8 | 5 | 1 | 0 |
| Phase 3 | 24 | 19 | 1 | 4 |
| Phase 4 | 14 | 11 | 0 | 2 |
| All trials | 70 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Later holder and Lead sponsor of trials | 2003 to now |
| Alcon | Later holder and Lead sponsor of trials | 2006 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2011 to now |
| Cornerstone Pharmaceuticals | Later holder | 2012 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Pari Pharma | Later holder and Lead sponsor of trials | 2013 to now |
| Chiesi | Acquired holder | 2014 to now |
| Pulmoflow | Later holder | 2014 to now |
| Eli Lilly | Applicant |