Naproxen · Regulatory label update

FDA supplemental approval: Naproxen (Labeling)

U.S. Food and Drug Administration · June 25, 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 an FDA supplemental approval for labeling changes to naproxen delayed-release tablets (375 mg and 500 mg formulations) submitted by Novitium Pharma. The record itself does not contain clinical trial results, efficacy data, or safety outcomes; it is a regulatory action affecting the approved product labeling.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory approval record; it does not contain clinical trial results or efficacy/safety data. No comparative benefit or safety data is reported.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval for naproxen labeling; it documents a regulatory action but does not report clinical trial outcomes or efficacy data.

Caveats

This is a regulatory approval record; it does not contain clinical trial results or efficacy/safety data.
The specific labeling changes approved are not detailed in this record.
No information on the rationale for the labeling supplement or what claims or warnings were modified.
No comparative benefit or safety data is reported.

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 record, not a clinical study.

Directness

insufficient

Labeling supplement does not report clinical endpoints or direct patient outcomes.

Consistency

insufficient

No comparative data or multiple studies reported in this record.

Risk of bias

insufficient

Regulatory labeling action; bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial sample described in this regulatory submission.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA218497. This is a regulatory action record, not a clinical study. Brand name: NAPROXEN. Active ingredient: NAPROXEN. Sponsor: NOVITIUM PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-25. Products: NAPROXEN, TABLET, DELAYED RELEASE, ORAL, NAPROXEN 375MG; NAPROXEN, TABLET, DELAYED RELEASE, ORAL, NAPROXEN 500MG.

Follow from this

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

Novitium PharmaNaproxen