Bosentan · Regulatory label update

FDA supplemental approval: Bosentan (Labeling)

U.S. Food and Drug Administration · April 14, 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 bosentan (generic tablets, 62.5 mg and 125 mg oral formulations) submitted by Watson Labs Inc. The record documents regulatory approval on 14 April 2026 but does not contain clinical trial results, efficacy data, or information about the specific labeling modifications.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory record only; no clinical trial results, efficacy data, comparative benefit, or safety outcomes are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for bosentan labeling update; regulatory action does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-14

Product strengths approved62.5 mg, 125 mg

Caveats

This is a regulatory record only; no clinical trial results, efficacy data, comparative benefit, or safety outcomes are reported.
The specific content of the labeling changes is not detailed in this source.
No information is provided about the clinical indication, patient population affected, or rationale for the labeling supplement.

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 reported.

Directness

insufficient

Labeling action; no clinical trial data or outcomes reported.

Consistency

insufficient

Single regulatory action; consistency not applicable.

Risk of bias

insufficient

Regulatory record; risk of 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 ANDA207110. This is a regulatory action record, not a clinical study. Brand name: BOSENTAN. Active ingredient: BOSENTAN. Sponsor: WATSON LABS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-14. Products: BOSENTAN, TABLET, ORAL, BOSENTAN 62.5MG; BOSENTAN, TABLET, ORAL, BOSENTAN 125MG.

Follow from this

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

BosentanWatson Labs