Cefazolin
As of the edition of 20 October 2026, Cefazolin is a small molecule: marketed, first approved in 1978 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Ancef
- First approved
- 6 October 1978 (ES)
- Approvals on record
- 23 in 4 regions
- Holder of the most recent approval
- B. Braun Medical; 8 holders in all
- Registered trials
- 83, 11 stopped early
- Disease areas
- Infections; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Cancer; Heart and blood vessels
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 | 28 | 16 | 3 | 3 |
| Phase 1 | 5 | 3 | 0 | 0 |
| Phase 2 | 5 | 3 | 1 | 0 |
| Phase 3 | 15 | 7 | 1 | 3 |
| Phase 4 | 30 | 14 | 10 | 5 |
| All trials | 83 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Later holder and Lead sponsor of trials | 1983 to now |
| B. Braun Medical | Acquired holder | 2003 to now |
| Hikma Pharmaceuticals | Later holder | 2022 to now |
| Hq Specialty Pharma | Later holder | 2023 to now |
| GSK | Applicant and Earlier holder |