Pomalidomide · Regulatory approval

FDA approval: Pomalidomide

U.S. Food and Drug Administration · August 31, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA has approved a generic pomalidomide product (ANDA213234) by Dr Reddy's in four oral capsule strengths (1 mg, 2 mg, 3 mg, and 4 mg) as of 31 August 2026. This is a bioequivalence approval record and does not contain clinical efficacy, safety trial data, or comparative outcome results.

What was studied

Regulatory approval. Intervention: Pomalidomide oral capsules: 1 mg, 2 mg, 3 mg, and 4 mg strengths.

Key findings

FDA approval granted for pomalidomide generic capsules in four strengths: 1 mg, 2 mg, 3 mg, and 4 mg

Safety

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or safety outcomes. Population studied, sample size, and any adverse event or efficacy data are not included in this record.

Who this may help

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

Plain-language summary

FDA approval of a generic pomalidomide formulation; confirms bioequivalence to reference but does not report clinical efficacy or comparative trial data.

Study design

As stated by the source record.

InterventionPomalidomide oral capsules: 1 mg, 2 mg, 3 mg, and 4 mg strengths

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-31

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or safety outcomes.
Bioequivalence studies supporting this ANDA approval are not described in this record.
No comparative efficacy versus reference pomalidomide or other agents is reported.
Population studied, sample size, and any adverse event or efficacy data are not included 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

Regulatory approval record; no clinical trial design described.

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative efficacy or safety data provided in this record.

Risk of bias

insufficient

Approval record contains no trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or population data stated in approval record.

Source abstract

Drugs@FDA record for application ANDA213234. This is a regulatory action record, not a clinical study. Brand name: POMALIDOMIDE. Active ingredient: POMALIDOMIDE. Sponsor: DR REDDYS. Submission type: ORIG (original application). Approval status date: 2026-08-31. 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.

DR ReddysPomalidomide