ACYCLOVIR SODIUM
ACYCLOVIR SODIUM is indicated for the treatment of Herpes Simplex Infections; Herpes Genitalis; Herpes Simplex Encephalitis; Neonatal Herpes Simplex Virus Infection; Varicella-Zoster.
Details
- Status
- Prescription
- First Approved
- 1997-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
ACYCLOVIR SODIUM Approval History
What ACYCLOVIR SODIUM Treats
5 indicationsACYCLOVIR SODIUM is approved for 5 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Simplex Infections
- Herpes Genitalis
- Herpes Simplex Encephalitis
- Neonatal Herpes Simplex Virus Infection
- Varicella-Zoster
ACYCLOVIR SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00855309 results posted | IRB00007690 P30CA012197, CCCWFU-98608 | Ph 3 | completed | Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia |
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.
ACYCLOVIR SODIUM FDA Label Details
Indications & Usage
ACYCLOVIR SODIUM is indicated for the treatment of Herpes Simplex Infections; Herpes Genitalis; Herpes Simplex Encephalitis; Neonatal Herpes Simplex Virus Infection; Varicella-Zoster.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.