Uzedy

Treats schizophrenia. NDA 213586, held by Teva. Risperidone.

As of Nov 13, 2026, NDA 213586 (Uzedy), held by Teva, was first approved by FDA on Apr 28, 2023, with 4 approved supplements and 1 published complete response letter.

First approved: Apr 28, 2023
Review: Standard
Supplements approved: 4
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

UZEDY is an atypical antipsychotic indicated: for the treatment of schizophrenia in adults. as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. 1.1 Schizophrenia UZEDY is indicated for the treatment of schizophrenia in adults. 1.2 Bipolar Disorder UZEDY is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Oct 10, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Apr 15, 2022	RisperidoneClinical, Identified Issue, Rationale For Concern	Approved

Products

7 strengths and forms


Uzedy50MG/0.14ML (50MG/0.14ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy75MG/0.21ML (75MG/0.21ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy100MG/0.28ML (100MG/0.28ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy125MG/0.35ML (125MG/0.35ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy150MG/0.42ML (150MG/0.42ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy200MG/0.56ML (200MG/0.56ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug
Uzedy250MG/0.7ML (250MG/0.7ML) · suspension, extended release;subcutaneous	Risperidone	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Oct 10, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 10, 2025	Supplement 9Labeling · Standard review	Approved	Letter Label
Jan 22, 2025	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 1, 2023	Supplement 1Labeling · Standard review	Approved	Letter
Apr 28, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 213586
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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