Data updated: Jun 28, 2026
ZAYNICH (cefepime hydrochloride)
Approved 2026-05-29
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-05-29
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ZAYNICH Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
May 2026 ORIGINAL Priority
Update · Type 1 - New Molecular Entity and Type 4 - New Combination
What ZAYNICH Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01484015 | IRB00015247 NCI-2011-02422, CCCWFU 02110 | Ph 1 | completed | Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia |
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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.
ZAYNICH FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.