Olmesartan Medoxomil AND Hydrochlorothiazide · Regulatory label update

FDA supplemental approval: Olmesartan Medoxomil AND Hydrochlorothiazide (Labeling)

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

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This record documents FDA supplemental approval of a labeling change for olmesartan medoxomil and hydrochlorothiazide combination tablets (three dose strengths) by Alkem Labs Ltd, approved 23 April 2026. The record itself contains no clinical trial results, efficacy data, comparative outcomes, or safety findings; it is an administrative action affecting product labeling only.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory labeling approval record; no clinical trial results, efficacy data, safety outcomes, or comparative evidence are reported. This record documents an administrative action only and does not support clinical efficacy or safety claims.

Who this may help

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

Plain-language summary

FDA supplemental approval of a labeling change for an existing combination antihypertensive; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-23

Dose strength 1HYDROCHLOROTHIAZIDE 25MG + OLMESARTAN MEDOXOMIL 40MG

Dose strength 2HYDROCHLOROTHIAZIDE 12.5MG + OLMESARTAN MEDOXOMIL 20MG

Dose strength 3HYDROCHLOROTHIAZIDE 12.5MG + OLMESARTAN MEDOXOMIL 40MG

Caveats

This is a regulatory labeling approval record; no clinical trial results, efficacy data, safety outcomes, or comparative evidence are reported.
The record does not specify what labeling changes were made or approved.
No sample size, patient population, study design, or outcome measures are provided.
This record documents an administrative action only and does not support clinical efficacy or safety claims.

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

This is a regulatory action, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical outcomes or comparators.

Consistency

insufficient

No comparative or outcome data reported in this record.

Risk of bias

insufficient

Regulatory labeling record; bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size reported.

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 ANDA207037. This is a regulatory action record, not a clinical study. Brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE. Active ingredient: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-23. Products: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 25MG + OLMESARTAN MEDOXOMIL 40MG; OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 12.5MG + OLMESARTAN MEDOXOMIL 20MG; OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 12.5MG + OLMESARTAN MEDOXOMIL 40MG.

Follow from this

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

Olmesartan Medoxomil AND HydrochlorothiazideAlkem Labs