Lopinavir AND Ritonavir · Regulatory label update

FDA supplemental approval: Kaletra (Labeling)

U.S. Food and Drug Administration · July 23, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval for a labeling change to Kaletra (lopinavir/ritonavir), approved 23 July 2026. The record is a regulatory action notification and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update. Intervention: Kaletra (lopinavir 100 mg + ritonavir 25 mg tablet; lopinavir 200 mg + ritonavir 50 mg tablet). United States (FDA).

Key findings

Safety

This is a regulatory record, not a clinical study; no trial outcomes, efficacy data, or safety results are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to Kaletra; regulatory action without clinical trial data or efficacy claims in the source.

Study design

As stated by the source record.

InterventionKaletra (lopinavir 100 mg + ritonavir 25 mg tablet; lopinavir 200 mg + ritonavir 50 mg tablet)

SettingUnited States (FDA)

Caveats

This is a regulatory record, not a clinical study; no trial outcomes, efficacy data, or safety results are reported.
The specific nature of the labeling change is not stated in the source.
No clinical evidence, comparator group, or effect sizes are provided.
The source does not indicate whether this approval is based on new data or administrative changes.

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 record; no study design applies.

Directness

insufficient

Labeling action does not report clinical outcomes or evidence.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed.

Risk of bias

insufficient

Regulatory submission; bias assessment not applicable to labeling action.

Sample adequacy

insufficient

No clinical sample reported in labeling record.

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

Source abstract

Drugs@FDA record for application NDA021906. This is a regulatory action record, not a clinical study. Brand name: KALETRA. Active ingredient: LOPINAVIR AND RITONAVIR. Sponsor: ABBVIE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-23. Products: KALETRA, TABLET, ORAL, LOPINAVIR 100MG + RITONAVIR 25MG; KALETRA, TABLET, ORAL, LOPINAVIR 200MG + RITONAVIR 50MG.

Follow from this

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

AbbvieLopinavir AND Ritonavir