Mycophenolate Mofetil · Regulatory label update

FDA supplemental approval: Cellcept (Labeling)

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

This record documents a supplemental FDA approval for a labeling change to CellCept (mycophenolate mofetil) oral suspension 200 mg/mL, approved 29 July 2026. The record confirms regulatory action but does not contain clinical trial results, efficacy data, safety outcomes, or the specific labeling modification approved.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory approval record, not a clinical study; no trial outcomes, efficacy data, or safety results are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to CellCept (mycophenolate mofetil); this is a regulatory action, not a clinical trial, and does not report efficacy or safety trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Product strength200 mg/mL

Formulationoral suspension

Caveats

This is a regulatory approval record, not a clinical study; no trial outcomes, efficacy data, or safety results are reported.
The specific nature and rationale of the labeling change are not detailed in this record.
No comparator, sample size, or clinical endpoint data are provided.
The record does not specify which indications, patient populations, or dosing recommendations were affected by this 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 action; no study design present.

Directness

insufficient

Labeling supplement; clinical outcomes not reported.

Consistency

insufficient

No comparative data or prior results discussed.

Risk of bias

insufficient

Not applicable to regulatory labeling action.

Sample adequacy

insufficient

No study population; regulatory record only.

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 NDA050759. This is a regulatory action record, not a clinical study. Brand name: CELLCEPT. Active ingredient: MYCOPHENOLATE MOFETIL. Sponsor: ROCHE PALO. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-29. Products: CELLCEPT, 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 MofetilRoche Palo