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Data updated: Nov 8, 2026

ZOVIRAX (acyclovir sodium) · GSK

Infectious Disease Approved 1982-03-29

ZOVIRAX is FDA-approved to treat 5 conditions (same as ACYCLOVIR SODIUM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
10
Indications
--
Phase 3 Trials
3
Priority Reviews
44
Years on Market

Details

Status
Discontinued
First Approved
1982-03-29
Routes
INJECTION, ORAL, TOPICAL
Dosage Forms
INJECTABLE, CAPSULE, SUSPENSION, OINTMENT, TABLET, CREAM

Companies

GSK PHARMOBEDIENT BAUSCH
Active Ingredient: ACYCLOVIR SODIUM

ZOVIRAX Approval History

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Original
New Indication
New Form
Label Update
193 FDA actions from 1982 to 2025 · 5 indication expansions
Nov 2025 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label
Jan 2019 SUPPL
Label · Labeling
FDA Letter Label

What ZOVIRAX Treats

5 indications

ZOVIRAX is approved for 5 conditions since its original approval in 1982. 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

Same approved indications as ACYCLOVIR SODIUM (same active ingredient).

Source: FDA Label
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ZOVIRAX FDA Label Details

Indications & Usage

FDA Label (PDF)

ZOVIRAX is FDA-approved to treat 5 conditions — same approved indications as ACYCLOVIR SODIUM.

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Data Sources

FDA Approval: NDA018603 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.