Pregabalin · Regulatory label update

FDA supplemental approval: Pregabalin (Labeling)

U.S. Food and Drug Administration · July 17, 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 record for a labeling change to pregabalin extended-release tablets (82.5 mg, 165 mg, and 330 mg) submitted by Alvogen under ANDA 211687, approved 17 July 2026. The record does not contain clinical trial data, efficacy results, or comparative benefit information; it documents only the regulatory action taken.

What was studied

Regulatory label update.

Key findings

Safety

This record describes a regulatory approval action only; no clinical trial results, efficacy data, safety outcomes, or comparator arms are reported. No information on underlying safety or efficacy studies is included.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for pregabalin extended-release tablets; this is a regulatory action, not a clinical evidence report.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-17

Application typeANDA211687 supplement (labeling)

SponsorALVOGEN

Products approvedPregabalin extended-release tablets: 82.5 mg, 165 mg, 330 mg oral

Caveats

This record describes a regulatory approval action only; no clinical trial results, efficacy data, safety outcomes, or comparator arms are reported.
The specific nature of the labeling change is not stated in this summary.
No information on underlying safety or efficacy studies is included.
This approval pertains to labeling (ANDA supplement class); it does not indicate new indication, new formulation efficacy, or comparative clinical benefit.

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 study design described.

Directness

insufficient

This is a labeling approval; clinical outcomes not reported.

Consistency

insufficient

Single regulatory record; no comparative or replication data given.

Risk of bias

insufficient

Regulatory approval does not assess trial bias; labeling only.

Sample adequacy

insufficient

No study sample or trial population described in this record.

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 ANDA211687. This is a regulatory action record, not a clinical study. Brand name: PREGABALIN. Active ingredient: PREGABALIN. Sponsor: ALVOGEN. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-17. Products: PREGABALIN, TABLET, EXTENDED RELEASE, ORAL, PREGABALIN 165MG; PREGABALIN, TABLET, EXTENDED RELEASE, ORAL, PREGABALIN 330MG; PREGABALIN, TABLET, EXTENDED RELEASE, ORAL, PREGABALIN 82.5MG.

Follow from this

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

AlvogenPregabalin