Losartan Potassium · Regulatory label update

FDA supplemental approval: Losartan Potassium (Labeling)

U.S. Food and Drug Administration · May 7, 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 supplemental FDA approval action for losartan potassium labeling submitted by TEVA on 7 May 2026. The record documents a regulatory decision to approve labeling changes but does not contain clinical trial data, efficacy findings, or safety comparative evidence.

What was studied

Regulatory label update. United States (FDA).

Key findings

Safety

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

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for losartan potassium labeling; it documents a regulatory decision but does not report clinical trial outcomes or efficacy data.

Study design

As stated by the source record.

SettingUnited States (FDA)

Caveats

This is a regulatory action record, not a clinical study; no trial outcomes, efficacy data, or safety trial results are reported.
The specific nature of the labeling change is not disclosed in this record.
No comparative efficacy or safety information is provided.
Patient population and inclusion criteria are not stated.

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 clinical study design applicable.

Directness

insufficient

Record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative efficacy or safety data provided in this record.

Risk of bias

insufficient

Regulatory approval document; clinical trial bias assessment not applicable.

Sample adequacy

insufficient

No patient population or sample size reported in this labeling approval.

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 ANDA076958. This is a regulatory action record, not a clinical study. Brand name: LOSARTAN POTASSIUM. Active ingredient: LOSARTAN POTASSIUM. Sponsor: TEVA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-07. Products: LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 50MG; LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 100MG; LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 25MG.

Follow from this

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

TevaLosartan Potassium