Mycophenolic Acid · Regulatory label update

FDA supplemental approval: Mycophenolic Acid (REMS)

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

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

This is an FDA supplemental approval (ANDA 208315) for delayed-release mycophenolate sodium tablets (180 mg and 360 mg base) under a Risk Evaluation and Mitigation Strategy (REMS) requirement. The record documents regulatory authorization only and does not report clinical trial results, efficacy endpoints, or comparative safety data.

What was studied

Regulatory label update. Intervention: Mycophenolate sodium delayed-release tablets: 180 mg base and 360 mg base formulations.

Key findings

FDA approved supplemental ANDA 208315 for REMS on mycophenolate sodium delayed-release tablets on 2026-07-29 Two formulations approved: 180 mg base and 360 mg base delayed-release oral tablets Sponsor: ALKEM LABS LTD

Safety

No efficacy, safety, or pharmacokinetic data are provided in this record.

Who this may help

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

Plain-language summary

FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on mycophenolic acid formulations; this is a regulatory action, not a clinical efficacy study.

Study design

As stated by the source record.

InterventionMycophenolate sodium delayed-release tablets: 180 mg base and 360 mg base formulations

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-29

ANDA number208315

Caveats

This is a regulatory approval record; no clinical trial results are reported.
No efficacy, safety, or pharmacokinetic data are provided in this record.
REMS approval indicates a risk mitigation requirement but does not describe the specific elements of the REMS.
No comparative benefit or superiority data versus other mycophenolic acid formulations are included.

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 record; no clinical study design involved.

Directness

insufficient

REMS approval is regulatory classification, not clinical outcome data.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No clinical population or sample size; regulatory submission only.

Source abstract

Drugs@FDA record for application ANDA208315. This is a regulatory action record, not a clinical study. Brand name: MYCOPHENOLIC ACID. Active ingredient: MYCOPHENOLIC ACID. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-07-29. Products: MYCOPHENOLATE SODIUM, TABLET, DELAYED RELEASE, ORAL, MYCOPHENOLATE SODIUM EQ 180MG BASE; MYCOPHENOLATE SODIUM, TABLET, DELAYED RELEASE, ORAL, MYCOPHENOLATE SODIUM EQ 360MG BASE.

Follow from this

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

Mycophenolic AcidAlkem Labs