Data updated: May 26, 2026
Kedrab (rabies immune globulin (human))
Approved 2017-08-22
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-08-22
- Routes
- Subcutaneous
- Dosage Forms
- Solution
Kedrab Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Aug 2017 ORIGINAL
Update · CBER biologic (Purple Book)
What Kedrab Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2017)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03965962 results posted | VRV13 2018-004055-20, U1111-1216-6151 | Ph 3 | completed | Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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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.
Kedrab FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.