FDA supplemental approval: Acyclovir (Labeling)

AI Summary

This record documents an FDA supplemental approval for acyclovir oral suspension (200 mg/5 mL) under ANDA 213951, submitted by Vistapharm LLC, with an approval date of 1 July 2026. The record reflects a labeling change only and contains no clinical trial data, efficacy results, or comparative safety information.

Plain-language summary

This is an FDA supplemental approval action for acyclovir oral suspension labeling; it documents a regulatory decision, not clinical evidence of efficacy or safety.

Caveats

• This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
• The specific nature of the labeling change is not detailed in this source.
• No comparative data, absolute or relative risk estimates, or clinical endpoints are reported.
• The record does not indicate whether this approval is for a new indication, new formulation, or labeling clarification.

Evidence assessment

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