Lenalidomide · Regulatory label update

FDA supplemental approval: Lenalidomide (REMS)

U.S. Food and Drug Administration · April 27, 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 application for lenalidomide capsules (2.5 mg, 5 mg, 15 mg, and 25 mg) manufactured by Torrent on 27 April 2026. This is a regulatory risk management action and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory REMS approval, not a clinical trial. The record does not contain efficacy data, safety outcomes, or clinical evidence.

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 lenalidomide; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Dosage strengths approved2.5 mg, 5 mg, 15 mg, 25 mg

Caveats

This is a regulatory REMS approval, not a clinical trial. The record does not contain efficacy data, safety outcomes, or clinical evidence.
The record does not specify what changes or updates to the existing REMS were implemented in this supplement.
No information on indication, patient population, prescriber requirements, or risk mitigation details is provided in this 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 action, not a clinical study.

Directness

insufficient

REMS approval record contains no clinical outcome data.

Consistency

insufficient

No comparative or outcome data reported in this record.

Risk of bias

insufficient

Not applicable to regulatory safety/REMS submission.

Sample adequacy

insufficient

No study population or sample size in this record.

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 ANDA213405. This is a regulatory action record, not a clinical study. Brand name: LENALIDOMIDE. Active ingredient: LENALIDOMIDE. Sponsor: TORRENT. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 5MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 15MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 25MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 2.5MG.

Follow from this

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

TorrentLenalidomide