Cefuroxime
As of the edition of 20 October 2026, Cefuroxime is a small molecule: marketed, first approved in 1983 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Zinacef
- First approved
- 21 March 1983 (FR)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Thea Pharma; 5 holders in all
- Registered trials
- 25, 1 stopped early
- Disease areas
- Infections; Digestive system; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Bones, joints and muscles
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 | 10 | 5 | 1 | 1 |
| Phase 1 | 2 | 0 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 11 | 8 | 2 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1983 to now |
| B. Braun Medical | Acquired holder | 2003 to now |
| Thea Pharma | Applicant | 2013 to now |
| Pharmaceutical Associates | Acquired holder | 2022 to now |