CYTOVENE (ganciclovir sodium) · CHEPLAPHARM
CYTOVENE is FDA-approved to treat 2 conditions (same as GANCICLOVIR SODIUM).
Details
- Status
- Discontinued
- First Approved
- 1989-06-23
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
CYTOVENE Approval History
What CYTOVENE Treats
2 indicationsCYTOVENE is approved for 2 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Cytomegalovirus Disease
Same approved indications as GANCICLOVIR SODIUM (same active ingredient).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03586284 STACCATO results posted | 18-24396 | Ph 2, Ph 3 | terminated | Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes |
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.
CYTOVENE FDA Label Details
Indications & Usage
FDA Label (PDF)CYTOVENE is FDA-approved to treat 2 conditions — same approved indications as GANCICLOVIR SODIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.