Loxapine Succinate

Sold as Loxitane. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 15, 2026, FDA lists 8 applications for Loxapine Succinate (sold as Loxitane), first approved Feb 25, 1975, with 1 new use approved and 0 published complete response letters.

First approved: Feb 25, 1975
Applications: 8
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $3.6M
First approved in the EU: Feb 20, 2013

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Loxapine	Part D	$3.6M	-1%	7,588

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LOXAPINE 10 MG CAPSULE: $0.464 per unitGeneric · -5% in a year
LOXAPINE 25 MG CAPSULE: $0.691 per unitGeneric · +18% in a year
LOXAPINE 5 MG CAPSULE: $0.322 per unitGeneric · -7% in a year
LOXAPINE 50 MG CAPSULE: $0.908 per unitGeneric · +3% in a year

Approvals in the EU (EMA)

First approved in the EU 456 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Adasuve, new substanceFerrer Internacional S.A. · Feb 20, 2013

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 25, 1975	LoxitaneNDA 17525 · New molecular entity	Teva Branded Pharm	36	Discontinued
Jun 15, 1988	Loxapine SuccinateANDA 72062	Watson Labs	17	Marketed
Jun 15, 1988	Loxapine SuccinateANDA 72204	Watson Labs	17	Marketed
Jun 15, 1988	Loxapine SuccinateANDA 72205	Watson Labs	19	Marketed
Jun 15, 1988	Loxapine SuccinateANDA 72206	Watson Labs	17	Marketed
Nov 1, 2004	Loxapine SuccinateANDA 76762	Rising	6	Discontinued
Aug 4, 2005	Loxapine SuccinateANDA 76868	Elite Labs Inc	5	Marketed
Sep 26, 2011	Loxapine SuccinateANDA 90695	Lannett Co Inc	2	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA