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 record documents FDA supplemental approval of a REMS for generic lenalidomide (5 mg, 10 mg, 15 mg, and 20 mg capsules) submitted by Hetero Labs Ltd on 27 April 2026. The approval applies to the risk mitigation strategy only and does not contain clinical efficacy, safety trial data, or comparative outcomes. Clinicians should refer to the approved REMS program requirements and the core prescribing information for lenalidomide.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for lenalidomide REMS (Risk Evaluation and Mitigation Strategy) Covers four oral capsule strengths: 5 mg, 10 mg, 15 mg, and 20 mg Approval date: 27 April 2026

Safety

This is a regulatory approval record and does not contain clinical trial results, efficacy data, safety comparisons, or patient outcome data. No information provided on bioavailability, equivalence studies, or comparative safety relative to reference product.

Who this may help

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

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for lenalidomide generic formulations; does not report clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-04-27

ANDA number212414

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, safety comparisons, or patient outcome data.
The record does not specify the clinical indications or approved uses; refer to the full prescribing information.
No information provided on bioavailability, equivalence studies, or comparative safety relative to reference product.
REMS approval address risk mitigation requirements only, not drug efficacy or clinical performance.

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 action record; no clinical study design reported.

Directness

insufficient

Record addresses regulatory approval pathway, not clinical outcomes.

Consistency

insufficient

No comparative data or trial results provided in source.

Risk of bias

insufficient

Not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No study population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA212414. This is a regulatory action record, not a clinical study. Brand name: LENALIDOMIDE. Active ingredient: LENALIDOMIDE. Sponsor: HETERO LABS LTD V. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 15MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 5MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 20MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 10MG.

Follow from this

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

Hetero Labs LTD VLenalidomide