Eluxadoline · Regulatory approval

FDA approval: Eluxadoline

U.S. Food and Drug Administration · June 2, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA approved a generic eluxadoline formulation (75 mg and 100 mg tablets) submitted by Aurobindo Pharma on 2 June 2026 under ANDA 213511. This is a regulatory action conferring market authorization; it does not report clinical trial results, efficacy data, or comparative benefit.

What was studied

Regulatory approval.

Key findings

Approval of ELUXADOLINE 75 mg tablet formulation Approval of ELUXADOLINE 100 mg tablet formulation Approved by FDA on 2 June 2026

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA approval of a generic eluxadoline formulation; establishes regulatory authorization but does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-02

Dosage strength approved (tablet 1)75 mg

Dosage strength approved (tablet 2)100 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative efficacy versus brand or other generic formulations is reported.
No information on bioequivalence study design, sample size, or results is provided in this regulatory record.
Approval status does not imply clinical superiority or establish new indication.

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 approval record; no clinical study design reported.

Directness

insufficient

Record does not specify clinical endpoints or patient populations studied.

Consistency

insufficient

No comparative efficacy or safety data provided in this approval record.

Risk of bias

insufficient

Regulatory record does not detail trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or clinical trial population data reported.

Source abstract

Drugs@FDA record for application ANDA213511. This is a regulatory action record, not a clinical study. Brand name: ELUXADOLINE. Active ingredient: ELUXADOLINE. Sponsor: AUROBINDO PHARMA. Submission type: ORIG (original application). Approval status date: 2026-06-02. Products: ELUXADOLINE, TABLET, ORAL, ELUXADOLINE 100MG; ELUXADOLINE, TABLET, ORAL, ELUXADOLINE 75MG.

Follow from this

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

Aurobindo PharmaEluxadoline