ROCEPHIN (ceftriaxone sodium) · Roche
ROCEPHIN is FDA-approved to treat 2 conditions (same as CEFTRIAXONE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1984-12-21
- Routes
- INJECTION, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE
ROCEPHIN Approval History
What ROCEPHIN Treats
2 indicationsROCEPHIN is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as CEFTRIAXONE (same active ingredient).
Roche's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04975945 | generalsurgery/2021/01 | Ph 4 | withdrawn | Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI |
| NCT05027516 ResistAZM results posted | ITM202101 | Ph 4 | completed | Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea |
| NCT01254344 results posted | 0826-056 | Ph 3 | completed | Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056) |
| NCT01473836 results posted | A6831005 | Ph 3 | completed | A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ROCEPHIN FDA Label Details
Indications & Usage
FDA Label (PDF)ROCEPHIN is FDA-approved to treat 2 conditions — same approved indications as CEFTRIAXONE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment