Exxua

Treats major depressive disorder (MDD). NDA 21164, held by Fabre Kramer. Gepirone Hydrochloride.

As of Nov 14, 2026, NDA 21164 (Exxua), held by Fabre Kramer, was first approved by FDA on Sep 22, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 22, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.

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
Sep 22, 2023	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


ExxuaEQ 18.2MG BASE · tablet, extended release;oral	Gepirone Hydrochloride	RxReference drug
ExxuaEQ 36.3MG BASE · tablet, extended release;oral	Gepirone Hydrochloride	RxReference drug
ExxuaEQ 54.5MG BASE · tablet, extended release;oral	Gepirone Hydrochloride	RxReference drug
ExxuaEQ 72.6MG BASE · tablet, extended release;oral	Gepirone Hydrochloride	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Jun 7, 2025	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 22, 2023	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21164
Drugs@FDA: Overview at FDA
Company: Fabre-Kramer Pharmaceuticals

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