Gepirone Hydrochloride

Treats major depressive disorder (MDD). Sold as Exxua. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Gepirone Hydrochloride (sold as Exxua), first approved Sep 22, 2023, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 22, 2023
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $0K

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Exxua	Part D	$0K	New	0

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

EXXUA ER 18.2 MG TAB (TITRATN): $57.56 per unitBrand · new this year
EXXUA ER 54.5 MG TABLET: $56.29 per unitBrand · new this year

Who Was in the Trials

442 participants in the largest population FDA reports for the Sep 22, 2023 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 65%
65 and older: under 1%
White: 69%
Black: 17%
Asian: 0%
Hispanic or Latino: 13%

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Sep 22, 2023	ExxuaNDA 21164 · New molecular entity	Fabre Kramer	1	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