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

This is a U.S. FDA supplemental approval (REMS) granted to Cipla for lenalidomide oral capsules in four strengths (5 mg, 15 mg, 20 mg, 25 mg) on 27 April 2026. The record confirms regulatory authorization of a risk mitigation strategy but does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update. United States.

Key findings

Safety

This 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 an existing drug; this is an administrative action, not a clinical evidence record.

Study design

As stated by the source record.

SettingUnited States

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Submission typeREMS supplement

Approved strengths5 mg, 15 mg, 20 mg, 25 mg oral capsules

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No information on the specific REMS requirements or mitigation measures is detailed in this record.
This is an administrative approval; the clinical basis for lenalidomide use remains in the original NDA, not this supplement.
No comparative data or effect sizes are reported.

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

Regulatory submission; clinical efficacy or safety data not reported here.

Consistency

insufficient

No comparative or replication data presented in this record.

Risk of bias

insufficient

Not applicable to a regulatory approval record.

Sample adequacy

insufficient

No trial population or sample size; regulatory submission 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 ANDA213165. This is a regulatory action record, not a clinical study. Brand name: LENALIDOMIDE. Active ingredient: LENALIDOMIDE. Sponsor: CIPLA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 25MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 15MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 5MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 20MG.

Follow from this

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

CiplaLenalidomide