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 approved a supplemental REMS for mycophenolate mofetil 500 mg tablet (oral) on 29 July 2026, submitted by Zhejiang Hisun Pharmaceuticals under application ANDA204076. This is a regulatory action governing risk mitigation requirements; the record does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil; a regulatory action without clinical trial data or efficacy assessment.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-29

Drug strength500 mg

Caveats

This record does not contain clinical trial results, efficacy outcomes, or safety data.
The record does not explain the specific REMS requirements or mitigation measures imposed.
No information on comparator products, patient population, or clinical indications is provided.
Regulatory approval of a REMS does not constitute evidence of clinical efficacy or superiority.

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

Record does not report clinical outcomes or comparative efficacy data.

Consistency

insufficient

No clinical data presented for consistency evaluation.

Risk of bias

insufficient

Regulatory submission; bias assessment does not apply.

Sample adequacy

insufficient

No patient 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 ANDA204076. This is a regulatory action record, not a clinical study. Brand name: MYCOPHENOLATE MOFETIL. Active ingredient: MYCOPHENOLATE MOFETIL. Sponsor: ZHEJIANG HISUN PHARM. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-07-29. Products: MYCOPHENOLATE MOFETIL, TABLET, ORAL, MYCOPHENOLATE MOFETIL 500MG.

Follow from this

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

Mycophenolate MofetilZhejiang Hisun Pharm