Fetzima

Treats major depressive disorder (MDD). NDA 204168, held by Abbvie. Levomilnacipran Hydrochloride.

As of Nov 13, 2026, NDA 204168 (Fetzima), held by Abbvie, was first approved by FDA on Jul 25, 2013, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2013
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FETZIMA is indicated for the treatment of major depressive disorder (MDD) in adults. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Mar 24, 2023	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 25, 2013	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


FetzimaEQ 20MG BASE · capsule, extended release;oral	Levomilnacipran Hydrochloride	RxReference drug
FetzimaEQ 40MG BASE · capsule, extended release;oral	Levomilnacipran Hydrochloride	RxReference drug
FetzimaEQ 80MG BASE · capsule, extended release;oral	Levomilnacipran Hydrochloride	RxReference drug
FetzimaEQ 120MG BASE · capsule, extended release;oral	Levomilnacipran Hydrochloride	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Apr 19, 2024	Supplement 12Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 18, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 24, 2023	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 20, 2021	Supplement 7Labeling	Approved	Label Letter
Oct 7, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 19, 2017	Supplement 5Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 4Labeling	Approved	Letter Label
Jun 5, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 2Labeling	Approved	Letter Label
May 23, 2014	Supplement 1Labeling · Standard review	Approved	Label Letter
Jul 25, 2013	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 204168
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