Pyridostigmine Bromide · Regulatory label update

FDA supplemental approval: Pyridostigmine Bromide (Labeling)

U.S. Food and Drug Administration · May 12, 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 regulatory approval action by the FDA for a supplemental labeling change to pyridostigmine bromide extended-release tablets (105 mg), approved 12 May 2026 by Amneal. The record documents the regulatory event but does not report clinical trial results, efficacy data, or the specific labeling changes made.

What was studied

Regulatory label update.

Key findings

Safety

No comparative evidence, safety data, or clinical outcomes are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for pyridostigmine bromide labeling change; regulatory action without clinical trial data or efficacy claims.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-12

Dose strength105 mg

Caveats

This record does not contain clinical trial results or efficacy data.
Specific labeling changes approved are not described in this source.
No comparative evidence, safety data, or clinical outcomes are reported.
Regulatory approval of a labeling supplement does not imply new clinical evidence or practice change.

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 record, not a clinical study; no trial design applicable.

Directness

insufficient

Labeling action only; no clinical outcome data reported or referenced.

Consistency

insufficient

Single regulatory submission; no comparative evidence provided.

Risk of bias

insufficient

Regulatory record does not contain or report trial methodology or bias assessment.

Sample adequacy

insufficient

No human subjects or sample size; regulatory action only.

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 NDA217604. This is a regulatory action record, not a clinical study. Brand name: PYRIDOSTIGMINE BROMIDE. Active ingredient: PYRIDOSTIGMINE BROMIDE. Sponsor: AMNEAL. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-12. Products: PYRIDOSTIGMINE BROMIDE, TABLET, EXTENDED RELEASE, ORAL, PYRIDOSTIGMINE BROMIDE 105MG.

Follow from this

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

Pyridostigmine BromideAmneal