Lurasidone Hydrochloride · Regulatory label update

FDA supplemental approval: Lurasidone Hydrochloride (Labeling)

U.S. Food and Drug Administration · May 14, 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 record for lurasidone hydrochloride labeling submitted by Zydus Pharma on 14 May 2026. The record documents a regulatory action only and does not report clinical trial data, efficacy outcomes, safety results, or comparative evidence.

What was studied

Regulatory label update.

Key findings

FDA approval of supplemental labeling application (ANDA208052) for lurasidone hydrochloride tablets in four strengths: 40 mg, 60 mg, 80 mg, and 120 mg oral formulations

Safety

This record documents a regulatory action only and does not contain clinical trial results, efficacy data, safety comparisons, or outcome measures.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for lurasidone hydrochloride formulations; this is a regulatory action record, not a clinical trial, and contains no efficacy or safety outcome data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-14

Formulations approved40 mg, 60 mg, 80 mg, 120 mg tablets

Caveats

This record documents a regulatory action only and does not contain clinical trial results, efficacy data, safety comparisons, or outcome measures.
No information on what labeling changes were approved or the clinical rationale for the supplemental submission is provided.
The record does not include sample sizes, endpoints, comparators, or any quantitative clinical evidence.

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 record, not a clinical study.

Directness

insufficient

Record documents approval action only; no clinical outcome data provided.

Consistency

insufficient

No comparative or outcome data presented in this regulatory record.

Risk of bias

insufficient

Not applicable to regulatory action documentation.

Sample adequacy

insufficient

Not applicable; record is administrative, not a clinical study.

Source abstract

Drugs@FDA record for application ANDA208052. This is a regulatory action record, not a clinical study. Brand name: LURASIDONE HYDROCHLORIDE. Active ingredient: LURASIDONE HYDROCHLORIDE. Sponsor: ZYDUS PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-14. Products: LURASIDONE HYDROCHLORIDE, TABLET, ORAL, LURASIDONE HYDROCHLORIDE 80MG; LURASIDONE HYDROCHLORIDE, TABLET, ORAL, LURASIDONE HYDROCHLORIDE 40MG; LURASIDONE HYDROCHLORIDE, TABLET, ORAL, LURASIDONE HYDROCHLORIDE 120MG; LURASIDONE HYDROCHLORIDE, TABLET, ORAL, LURASIDONE HYDROCHLORIDE 60MG.

Follow from this

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

Zydus PharmsLurasidone Hydrochloride