Is Loxapine approved by the US FDA?

Drugs@FDA lists 12 application product lines for Loxapine, including LOXAPINE SUCCINATE (Prescription); LOXAPINE SUCCINATE (Prescription); LOXAPINE SUCCINATE (Prescription); LOXAPINE SUCCINATE (Prescription); LOXAPINE SUCCINATE (Prescription).

Is Loxapine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Loxapine: Adasuve.

Are there safety signals or safety updates for Loxapine?

US FDA: 4 entries (latest 2025-01-22).

Active substance

Loxapine

US FDA 12
EMA 1
Health Canada 4
US price lines 4
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LOXAPINE SUCCINATE	EQ 50MG BASE	capsule · oral	WATSON LABS	Prescription	15 Jun 1988
LOXAPINE SUCCINATE	EQ 5MG BASE	capsule · oral	WATSON LABS	Prescription	15 Jun 1988
LOXAPINE SUCCINATE	EQ 10MG BASE	capsule · oral	WATSON LABS	Prescription	15 Jun 1988
LOXAPINE SUCCINATE	EQ 25MG BASE	capsule · oral	WATSON LABS	Prescription	15 Jun 1988
LOXAPINE SUCCINATE	EQ 5MG BASE; EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE	capsule · oral	ELITE LABS INC	Prescription	4 Aug 2005
LOXAPINE SUCCINATE	EQ 5MG BASE; EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE	capsule · oral	LANNETT CO INC	Prescription	26 Sep 2011
ADASUVE	10MG	powder · inhalation	NOVA PNEUMA	Prescription	21 Dec 2012
LOXITANE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	TEVA BRANDED PHARM	Discontinued	25 Feb 1975
LOXITANE	EQ 10MG BASE Federal Register determination that product was discontinued or withdrawn for s or e reasons; EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TEVA BRANDED PHARM	Discontinued	25 Feb 1975
LOXITANE C	EQ 25MG BASE/ML	concentrate · oral	TEVA BRANDED PHARM	Discontinued	4 May 1976
LOXITANE IM	EQ 50MG BASE/ML	injectable · injection	ACTAVIS LABS UT INC	Discontinued	26 Oct 1979
LOXAPINE SUCCINATE	EQ 5MG BASE; EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE	capsule · oral	RISING	Discontinued	1 Nov 2004

EMA European Union — centrally authorised medicines

Adasuve Ferrer Internacional S.A. · Authorised · authorised 20 Feb 2013 · ATC N05AH01

Therapeutic indication (EMA)

Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LOXAPAC IM	02169991	50 MG / ML	SOLUTION · INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
XYLAC	02230838	10 MG	TABLET · ORAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
XYLAC	02230839	25 MG	TABLET · ORAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
XYLAC	02242868	2.5 MG	TABLET · ORAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LOXAPINE 10 MG CAPSULE	$0.46824	per EA	23 Sep 2026
US NADAC	LOXAPINE 25 MG CAPSULE	$0.69476	per EA	23 Sep 2026
US NADAC	LOXAPINE 5 MG CAPSULE	$0.30917	per EA	23 Sep 2026
US NADAC	LOXAPINE 50 MG CAPSULE	$0.95202	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 22 Jan 2025 LOXITANE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 22 Jan 2025 LOXITANE C — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 27 Oct 2021 ADASUVE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Feb 2017 LOXITANE IM — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for loxapine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.