TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ACYCLOVIR

ACYCLOVIR DNA Polymerase Inhibitors
Infectious Disease Approved 1997-04-22
57
Indications
--
Phase 3 Trials
28
Years on Market

ACYCLOVIR Approval History

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What ACYCLOVIR Treats

3 indications

ACYCLOVIR 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
Source: FDA Label

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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.

ACYCLOVIR FDA Label Details

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Indications & 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.