Levomilnacipran Hydrochloride

Treats major depressive disorder (MDD). Sold as Fetzima. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 15, 2026, FDA lists 5 applications for Levomilnacipran Hydrochloride (sold as Fetzima), first approved Jul 25, 2013, with 2 new uses approved and 0 published complete response letters.

First approved: Jul 25, 2013
Applications: 5
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $26.3M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Fetzima	Part D	$26.3M	-3%	5,584

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

FETZIMA 20-40 MG TITRATION PAK: $17.61 per unitBrand · +5% in a year
FETZIMA ER 120 MG CAPSULE: $17.59 per unitBrand · +5% in a year
FETZIMA ER 20 MG CAPSULE: $17.60 per unitBrand · +5% in a year
FETZIMA ER 40 MG CAPSULE: $17.60 per unitBrand · +5% in a year
FETZIMA ER 80 MG CAPSULE: $17.59 per unitBrand · +5% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023

Applications

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


Jul 25, 2013	FetzimaNDA 204168 · New active ingredient	Abbvie	10	Marketed
Feb 4, 2019	Levomilnacipran HydrochlorideANDA 210790	Amneal Pharms Co	5	Discontinued
Nov 5, 2020	Levomilnacipran HydrochlorideANDA 210732	Hikma	2	Discontinued
Jan 6, 2023	Levomilnacipran HydrochlorideANDA 210826	Aurobindo Pharma Ltd	0	Discontinued
Mar 20, 2023	Levomilnacipran HydrochlorideANDA 210771	Prinston	0	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