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 Risk Evaluation and Mitigation Strategy (REMS) application for lenalidomide oral capsules (Amneal, ANDA 216213) on 27 April 2026, covering four strengths (2.5 mg, 10 mg, 20 mg, 25 mg). This is a regulatory administrative action and does not include clinical efficacy, safety trial results, or comparative outcome data.

What was studied

Regulatory label update.

Key findings

FDA approval granted for lenalidomide REMS supplement on 2026-04-27 Four oral capsule strengths approved: 2.5 mg, 10 mg, 20 mg, 25 mg Sponsor: Amneal; submission class: REMS (Risk Evaluation and Mitigation Strategy)

Safety

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

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; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Approved strengths2.5 mg, 10 mg, 20 mg, 25 mg

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
REMS approval does not imply comparative clinical benefit or new therapeutic indication.
No patient population, dosing regimen, indication, or clinical endpoints are described 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 record, not a clinical study.

Directness

insufficient

No clinical outcomes or trial data reported in this regulatory record.

Consistency

insufficient

No comparative or replication data provided in regulatory approval record.

Risk of bias

insufficient

Regulatory action does not report clinical trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical sample or patient population data reported in this record.

Source abstract

Drugs@FDA record for application ANDA216213. This is a regulatory action record, not a clinical study. Brand name: LENALIDOMIDE. Active ingredient: LENALIDOMIDE. Sponsor: AMNEAL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 20MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 10MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 2.5MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 25MG.

Follow from this

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

AmnealLenalidomide