ACYCLOVIR
Details
- Status
- Prescription
- First Approved
- 1997-04-22
- Routes
- TOPICAL, ORAL, INJECTION
- Dosage Forms
- OINTMENT, CREAM, SUSPENSION, TABLET, CAPSULE, INJECTABLE
Companies
ACYCLOVIR Approval History
What ACYCLOVIR Treats
3 indicationsACYCLOVIR is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Zoster
- Genital Herpes
- Chickenpox
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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 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Herpes Zoster Infections : Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes : Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox : Acyclovir is indicated for the treatment of chickenpox (varicella).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.