Viibryd

Treats major depressive disorder (MDD). NDA 22567, held by Abbvie. Vilazodone Hydrochloride.

As of Nov 14, 2026, NDA 22567 (Viibryd), held by Abbvie, was first approved by FDA on Jan 21, 2011, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 21, 2011
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIIBRYD 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 20 submissions below


Jan 31, 2020	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 16, 2015	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 21, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Viibryd10MG · tablet;oral	Vilazodone Hydrochloride	RxReference drug
Viibryd20MG · tablet;oral	Vilazodone Hydrochloride	RxReference drug
Viibryd40MG · tablet;oral	Vilazodone Hydrochloride	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Apr 19, 2024	Supplement 25Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 18, 2023	Supplement 24Labeling · Standard review	Approved	Letter Label
Sep 20, 2021	Supplement 22Labeling	Approved	Label Letter
Jan 31, 2020	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 4, 2017	Supplement 20Labeling	Approved	Letter Label
Sep 6, 2016	Supplement 19Labeling	Approved	Letter Label
Dec 16, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 11, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 16, 2015	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 16, 2014	Supplement 13Labeling	Approved	Letter Label
Apr 17, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 7, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 17, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Jun 8, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 10, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 21, 2012	Supplement 5Labeling · Standard review	Approved	Label Letter
Dec 14, 2012	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 21, 2011	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 29, 2011	Supplement 2REMS	Approved	Letter
Jan 21, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22567
Drugs@FDA: Overview at FDA
Company: AbbVie

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