Data updated: Mar 29, 2026
ZEMDRI
PLAZOMICIN SULFATE
Approved 2018-06-25
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2018-06-25
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ZEMDRI Approval History
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What ZEMDRI Treats
2 indicationsZEMDRI is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complicated Urinary Tract Infection
- Pyelonephritis
Source: FDA Label
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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.
ZEMDRI FDA Label Details
ProZEMDRI Patents & Exclusivity
Latest Patent: Jun 2032
Exclusivity: Jun 2028
Patents (4 active)
Exclusivity
NCE
Until Jun 2023
GAIN
Until Jun 2028
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.