Mycophenolate Mofetil · Regulatory label update

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration · July 29, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA granted a supplemental approval to Aurobindo Pharma for mycophenolate mofetil oral suspension under a REMS (Risk Evaluation and Mitigation Strategy) framework, effective 29 July 2026. This is a regulatory action addressing risk management requirements, not a report of clinical efficacy or safety findings from a trial.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for mycophenolate mofetil 200 mg/mL oral suspension formulation Approval date: 29 July 2026 Sponsor: Aurobindo Pharma Ltd

Safety

This record does not contain clinical trial data, efficacy comparisons, or safety findings. Sponsor: Aurobindo Pharma Ltd

Who this may help

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

Plain-language summary

FDA supplemental approval action for REMS modification; does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Application numberANDA218227

Approval status date2026-07-29

Formulation strength200 mg/mL

Caveats

This record does not contain clinical trial data, efficacy comparisons, or safety findings.
REMS approval indicates risk management requirements but the specific terms of the mitigation strategy are not detailed in this record.
No information on clinical outcomes, patient populations, or comparative benefit is provided.

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

No clinical outcome or efficacy data reported in this record.

Consistency

insufficient

Single regulatory action; no comparative or replication data.

Risk of bias

insufficient

Not applicable to a regulatory approval record.

Sample adequacy

insufficient

Not applicable to a regulatory approval record.

Source abstract

Drugs@FDA record for application ANDA218227. This is a regulatory action record, not a clinical study. Brand name: MYCOPHENOLATE MOFETIL. Active ingredient: MYCOPHENOLATE MOFETIL. Sponsor: AUROBINDO PHARMA LTD. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-07-29. Products: MYCOPHENOLATE MOFETIL, FOR SUSPENSION, ORAL, MYCOPHENOLATE MOFETIL 200MG/ML.

Follow from this

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

Mycophenolate MofetilAurobindo Pharma