Glipizide · Regulatory label update

FDA supplemental approval: Glipizide AND Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · August 11, 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 for a labeling change to an existing combination tablet of glipizide and metformin hydrochloride, sponsored by Novitium Pharma. The record does not contain clinical trial results, efficacy data, or safety analysis; it documents only the regulatory approval of modified labeling for three tablet strength formulations.

What was studied

Regulatory label update.

Key findings

Safety

This record contains no clinical trial results, efficacy data, safety outcomes, or comparative analysis. No information on indication, dosing recommendations, contraindications, or adverse events is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval of a labeling change for an existing combination drug product; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-11

Formulation 1GLIPIZIDE 5MG + METFORMIN HYDROCHLORIDE 500MG, TABLET, ORAL

Formulation 2GLIPIZIDE 2.5MG + METFORMIN HYDROCHLORIDE 250MG, TABLET, ORAL

Formulation 3GLIPIZIDE 2.5MG + METFORMIN HYDROCHLORIDE 500MG, TABLET, ORAL

Caveats

This record contains no clinical trial results, efficacy data, safety outcomes, or comparative analysis.
The specific labeling changes approved are not detailed in this record.
No information on indication, dosing recommendations, contraindications, or adverse events is provided.
This is a supplemental approval; baseline approval of the drug combination is not described here.

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 record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative data or consistency assessment provided in record.

Risk of bias

insufficient

Not applicable to regulatory labeling approval record.

Sample adequacy

insufficient

No clinical study population or sample size reported.

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 ANDA078083. This is a regulatory action record, not a clinical study. Brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE. Active ingredient: GLIPIZIDE. Sponsor: NOVITIUM PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: GLIPIZIDE AND METFORMIN HYDROCHLORIDE, TABLET, ORAL, GLIPIZIDE 5MG + METFORMIN HYDROCHLORIDE 500MG; GLIPIZIDE AND METFORMIN HYDROCHLORIDE, TABLET, ORAL, GLIPIZIDE 2.5MG + METFORMIN HYDROCHLORIDE 250MG; GLIPIZIDE AND METFORMIN HYDROCHLORIDE, TABLET, ORAL, GLIPIZIDE 2.5MG + METFORMIN HYDROCHLORIDE 500MG.

Follow from this

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

GlipizideNovitium Pharma