← FDA DRUG APPROVALS

FDA NDA · NDA209500

CAPLYTA

lumateperone

Sponsor: INTRA-CELLULAR

APPLICATION
NDA209500
TYPE
NDA
ORIGINAL APPROVAL
2019-12-20
LATEST ACTION
2026-04-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CAPLYTA · ReferencePrescription
LUMATEPERONE TOSYLATE EQ 21MG BASE · CAPSULE · ORAL
CAPLYTA · ReferencePrescription
LUMATEPERONE TOSYLATE EQ 42MG BASE · CAPSULE · ORAL
CAPLYTA · ReferencePrescription
LUMATEPERONE TOSYLATE EQ 10.5MG BASE · CAPSULE · ORAL

Approval history

2026-04-24Efficacy · Supplement 17 · standard — Letter ↗AP
2025-11-05Efficacy · Supplement 16 · standard — Letter ↗AP
2023-06-28Labeling · Supplement 11 · standard — Letter ↗AP
2022-04-26Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2021-12-17Efficacy · Supplement 6 · standard — Label ↗AP
2021-12-17Efficacy · Supplement 5 · standard — Label ↗AP
2019-12-20Type 1 - New Molecular Entity · Original · standard — Review ↗AP
2019-12-20Type 1 - New Molecular Entity · Supplement 1 · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →