Lisdexamfetamine Dimesylate · Regulatory label update

FDA supplemental approval: Vyvanse (Labeling)

U.S. Food and Drug Administration · April 23, 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 a U.S. FDA supplemental approval for a labeling change to Vyvanse (lisdexamfetamine dimesylate) granted on 23 April 2026. The submission is a regulatory action and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling change for Vyvanse (lisdexamfetamine dimesylate); this is a regulatory action, not a clinical trial, and does not report efficacy or comparative benefit data.

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific nature and content of the labeling change are not detailed in this record.
No information on patient population, indication, or dosing rationale is provided.
Regulatory approval of a labeling change does not indicate new clinical benefit or comparative advantage.

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 submission record, not a clinical study.

Directness

insufficient

No clinical outcome data reported in this regulatory record.

Consistency

insufficient

Single regulatory action; no comparative or replicated evidence provided.

Risk of bias

insufficient

Not applicable to regulatory submission classification.

Sample adequacy

insufficient

No clinical trial sample reported in this regulatory record.

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 NDA021977. This is a regulatory action record, not a clinical study. Brand name: VYVANSE. Active ingredient: LISDEXAMFETAMINE DIMESYLATE. Sponsor: TAKEDA PHARMS USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-23. Products: VYVANSE, CAPSULE, ORAL, LISDEXAMFETAMINE DIMESYLATE 60MG; VYVANSE, CAPSULE, ORAL, LISDEXAMFETAMINE DIMESYLATE 20MG; VYVANSE, CAPSULE, ORAL, LISDEXAMFETAMINE DIMESYLATE 50MG; VYVANSE, CAPSULE, ORAL, LISDEXAMFETAMINE DIMESYLATE 10MG.

Follow from this

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

Lisdexamfetamine DimesylateTakeda Pharms U