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

On 29 July 2026, the FDA approved a supplemental application (ANDA 214525) establishing a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil oral suspension (200 mg/mL) manufactured by Quagen. This regulatory action does not report clinical trial outcomes or efficacy data; it documents a risk management requirement for the product.

What was studied

Regulatory label update. United States (FDA).

Key findings

REMS approval granted for mycophenolate mofetil oral suspension 200 mg/mL Approval date: 29 July 2026 Sponsor: Quagen

Safety

No comparative or baseline safety or efficacy data are reported.

Who this may help

This record does not contain clinical efficacy or safety trial data. Clinicians should consult the product labelling and REMS programme details for information on indication, contraindications, and required patient monitoring or educational requirements.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil; this is a regulatory action, not a clinical evidence report.

Study design

As stated by the source record.

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Concentration200 mg/mL

Application numberANDA214525

Clinical bottom line

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or outcome measures.
No information is provided about the content or requirements of the REMS programme itself.
No comparative or baseline safety or efficacy data are reported.
Population, sample size, and clinical endpoints are not applicable to this regulatory record.

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 record, not a clinical study.

Directness

insufficient

Record describes regulatory action, not clinical endpoints or patient outcomes.

Consistency

insufficient

No comparative data or multiple studies reported in this record.

Risk of bias

insufficient

Not applicable; this is a regulatory approval document.

Sample adequacy

insufficient

No patient population or sample size data reported.

Source abstract

Drugs@FDA record for application ANDA214525. This is a regulatory action record, not a clinical study. Brand name: MYCOPHENOLATE MOFETIL. Active ingredient: MYCOPHENOLATE MOFETIL. Sponsor: QUAGEN. 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 MofetilQuagen