Latuda

Treats schizophrenia. NDA 200603, held by Sunovion Pharms Inc. Lurasidone Hydrochloride.

As of Nov 14, 2026, NDA 200603 (Latuda), held by Sunovion Pharms Inc, was first approved by FDA on Oct 28, 2010, with 27 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2010
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression). Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression). LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1, 14.1 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1, 14.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Mar 5, 2018	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Jan 27, 2017	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Medical Review
Jan 27, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Pediatric Medical Review Pediatric Statistical Review Label Letter
Jun 28, 2013	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 26, 2012	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 28, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

5 strengths and forms


Latuda40MG · tablet;oral	Lurasidone Hydrochloride	RxReference drug
Latuda80MG · tablet;oral	Lurasidone Hydrochloride	RxReference drug
Latuda20MG · tablet;oral	Lurasidone Hydrochloride	RxReference drug
Latuda120MG · tablet;oral	Lurasidone Hydrochloride	RxReference drug
Latuda60MG · tablet;oral	Lurasidone Hydrochloride	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 41Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 4, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Mar 5, 2018	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Sep 25, 2017	Supplement 30Labeling · Standard review	Approved	Label Letter
Feb 23, 2017	Supplement 28Labeling	Approved	Letter Label
Jan 27, 2017	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Medical Review
Jan 27, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Pediatric Medical Review Pediatric Statistical Review Label Letter
Jan 11, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 20, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 8, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 29, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 30, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
May 21, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 3, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Jul 12, 2013	Supplement 15Manufacturing · Standard review	Approved	Label
Jun 28, 2013	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 13, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 22, 2013	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 22, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 26, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Apr 26, 2012	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 7, 2011	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 7, 2011	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 10, 2010	Supplement 1Labeling · Standard review	Approved	Letter Label
Oct 28, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 200603
Drugs@FDA: Overview at FDA
Company: Sunovion Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters