Erzofri

Treats schizophrenia. NDA 216352, held by Luye Innomind Pharma. Paliperidone Palmitate.

As of Nov 14, 2026, NDA 216352 (Erzofri), held by Luye Innomind Pharma, was first approved by FDA on Jul 26, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 26, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ERZOFRI is indicated for the treatment of: Schizophrenia in adults. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ERZOFRI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 26, 2024	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

6 strengths and forms


Erzofri39MG/0.25ML (39MG/0.25ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug
Erzofri78MG/0.5ML (78MG/0.5ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug
Erzofri117MG/0.75ML (117MG/0.75ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug
Erzofri156MG/ML (156MG/ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug
Erzofri234MG/1.5ML (156MG/ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug
Erzofri351MG/2.25ML (156MG/ML) · suspension, extended release;intramuscular	Paliperidone Palmitate	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 26, 2024	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 216352
Drugs@FDA: Overview at FDA
Company: Luye Innomind Pharma

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