Valacyclovir · Regulatory label update

FDA supplemental approval: Valacyclovir (Labeling)

U.S. Food and Drug Administration · June 10, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is a U.S. FDA supplemental approval action for a labeling change to valacyclovir hydrochloride tablets (500 mg and 1 g formulations) submitted by Hetero Labs Ltd, approved on 10 June 2026. The record documents regulatory authorization only and does not contain clinical trial results, efficacy data, or comparative benefit information.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, study design, sample size, or efficacy/safety outcome data.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling changes for valacyclovir tablets; does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-10

Product strengths500 mg and 1 g base equivalents

Caveats

This record does not contain clinical trial results, study design, sample size, or efficacy/safety outcome data.
Specific labeling changes are not detailed in this regulatory record.
No information on indication, comparator, or clinical trial outcomes is provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action record; no study design reported.

Directness

insufficient

Labeling action; clinical outcomes not reported.

Consistency

insufficient

No comparative or internal consistency data provided.

Risk of bias

insufficient

Not applicable to labeling approval; no trial data reported.

Sample adequacy

insufficient

No sample or trial population described in this record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA203047. This is a regulatory action record, not a clinical study. Brand name: VALACYCLOVIR. Active ingredient: VALACYCLOVIR. Sponsor: HETERO LABS LTD V. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-10. Products: VALACYCLOVIR HYDROCHLORIDE, TABLET, ORAL, VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE; VALACYCLOVIR HYDROCHLORIDE, TABLET, ORAL, VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Hetero Labs LTD VValacyclovir