Pomalidomide · Regulatory label update

FDA supplemental approval: Pomalidomide (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 an FDA supplemental approval action, dated 27 April 2026, granting REMS designation to Apotex's generic pomalidomide in four oral capsule strengths (1 mg, 2 mg, 3 mg, 4 mg). REMS approval indicates that the agency has determined risk mitigation requirements are necessary; the record does not report clinical trial data, efficacy, safety outcomes, or comparative benefit.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval for pomalidomide generic (ANDA210164) by Apotex, effective 27 April 2026 Four strength formulations approved: 1 mg, 2 mg, 3 mg, and 4 mg oral capsules

Safety

This record does not contain clinical trial results, efficacy data, or safety outcome measures.

Who this may help

This is a regulatory action governing how pomalidomide is dispensed and monitored; it does not report efficacy or comparative safety data. Clinicians should refer to the approved REMS program requirements for prescribing, dispensing, and patient monitoring obligations.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide generic formulations; a regulatory action, not a clinical efficacy or safety trial.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Dosage forms approved1 mg, 2 mg, 3 mg, 4 mg capsules, oral

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcome measures.
No information on REMS program requirements, restrictions, or specific risk mitigation strategies is provided in this notice.
No comparative clinical data with branded or other generic pomalidomide formulations is reported.
Approval date is in the future (2026), which may indicate a forecast or prospective record rather than a completed action.

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 approval record; no clinical study design reported.

Directness

insufficient

Record does not address clinical outcomes or direct clinical evidence.

Consistency

insufficient

No comparative data or consistency assessment reported in this record.

Risk of bias

insufficient

Regulatory approval record does not contain or assess trial bias.

Sample adequacy

insufficient

No sample size or population data reported in regulatory notice.

Source abstract

Drugs@FDA record for application ANDA210164. This is a regulatory action record, not a clinical study. Brand name: POMALIDOMIDE. Active ingredient: POMALIDOMIDE. Sponsor: APOTEX. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: POMALIDOMIDE, CAPSULE, ORAL, POMALIDOMIDE 3MG; POMALIDOMIDE, CAPSULE, ORAL, POMALIDOMIDE 1MG; POMALIDOMIDE, CAPSULE, ORAL, POMALIDOMIDE 4MG; POMALIDOMIDE, CAPSULE, ORAL, POMALIDOMIDE 2MG.

Follow from this

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

PomalidomideApotex