Mirtazapine

Treats major depressive disorder (MDD). Sold as Remeron, Remeron Soltab. Every FDA application for this active ingredient: 2 branded and 24 generic.

As of Nov 15, 2026, FDA lists 26 applications for Mirtazapine (sold as Remeron, Remeron Soltab), first approved Jun 14, 1996, with 1 new use approved and 0 published complete response letters.

First approved: Jun 14, 1996
Applications: 26
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $149M
First approved in Japan: Jul 7, 2009

Medicare Spending

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


Mirtazapine	Part D	$149M	-6%	1,733,141
Remeron	Part D	$688K	-6%	416

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

MIRTAZAPINE 15 MG ODT: $0.308 per unitGeneric · -16% in a year
MIRTAZAPINE 15 MG TABLET: $0.062 per unitGeneric · -13% in a year
MIRTAZAPINE 30 MG ODT: $0.403 per unitGeneric · +0% in a year
MIRTAZAPINE 30 MG TABLET: $0.090 per unitGeneric · +0% in a year
MIRTAZAPINE 45 MG ODT: $0.424 per unitGeneric · -12% in a year
MIRTAZAPINE 45 MG TABLET: $0.118 per unitGeneric · +5% in a year
MIRTAZAPINE 7.5 MG TABLET: $0.343 per unitGeneric · -10% in a year
REMERON 15 MG TABLET: $6.36 per unitBrand · +3% in a year
REMERON 30 MG TABLET: $6.67 per unitBrand · +5% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

treatment of amyotrophic lateral sclerosis4B Technologies Limited · designated Apr 15, 2025

Approvals in Japan (PMDA)

First approved in Japan 157 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Remeron, new ingredientDrugs with a new active ingredient indicated for the treatment of depression. · Meiji Seika Kaisha, Ltd. · Jul 7, 2009

Clinical Trials

17 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


PBPK Modeling and Clinical Validation of Mirtazapine in the Vietnamese Population: Integration of Bioequivalence Data and Evaluation of the Impact of Physiological and Metabolic VariabilityMirtazapine Pharmacokinetics, Pharmacokinetic Variability · Haiphong University of Medicine and Pharmacy	Phase 1	Active, not recruiting	Nov 13, 2026
Discontinuing Psychotropic Medication Before Psychotherapy for PTSDPost-traumatic Stress Disorder (PTSD) · Academic Centre for Dentistry in Amsterdam	—	Not yet recruiting	Sep 3, 2026
Biomarkers and Pharmacogenomics for Precision Depression TherapyDepression / Major Depressive Disorder · The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Not applicable	Not yet recruiting	Jul 31, 2026
Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in ChinaAnxiety Depression, Sleep · Duke Kunshan University	Phase 4	Recruiting	Apr 27, 2026
Repurposing Mirtazapine in Rett SyndromeRETT Syndrome With Proven MECP2 Mutation · University of Trieste	Phase 2	Recruiting	Feb 24, 2026
Neurobiological and Genomic Predictors of Relapse in DepressionHealthy, Major Depressive Disorder (MDD) · Mehmet Kemal Arikan	—	Recruiting	Jan 9, 2026
Methamphetamine Use Disorder Support in Heart Failure Pilot StudyHeart Failure, Methamphetamine Use Disorder · University of Southern California	Not applicable	Not yet recruiting	Oct 8, 2025
Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a NeuromodulatorIBS - Irritable Bowel Syndrome, Diarrhea · Mayo Clinic	Early phase 1	Recruiting	Nov 12, 2024

Applications

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


Jun 14, 1996	RemeronNDA 20415 · New molecular entity	Organon	30	Marketed
Jan 12, 2001	Remeron SoltabNDA 21208 · New dosage form	Organon USA Organon	22	Marketed
Jan 24, 2003	MirtazapineANDA 76119	Teva	13	Marketed
Jun 19, 2003	MirtazapineANDA 76122	Mylan	13	Marketed
Jun 19, 2003	MirtazapineANDA 76176	Pharmazone	7	Discontinued
Jun 19, 2003	MirtazapineANDA 76189	Upsher Smith Labs	0	Discontinued
Jun 19, 2003	MirtazapineANDA 76219	Chartwell Rx	14	Marketed
Jun 19, 2003	MirtazapineANDA 76270	Roxane	2	Discontinued
Jun 19, 2003	MirtazapineANDA 76312	Watson Labs	8	Discontinued
Jun 20, 2003	MirtazapineANDA 76308	Actavis Elizabeth	0	Discontinued
Jun 20, 2003	MirtazapineANDA 76336	Actavis Labs Fl Inc	4	Discontinued
Jun 25, 2003	MirtazapineANDA 76241	Actavis Elizabeth	7	Discontinued
Dec 17, 2003	MirtazapineANDA 76307	Actavis Labs Fl Inc	11	Discontinued
Dec 22, 2003	MirtazapineANDA 76244	Ivax Sub Teva Pharms	4	Discontinued
Apr 22, 2004	MirtazapineANDA 76541	Sun Pharm Inds Inc	15	Marketed
Oct 22, 2004	MirtazapineANDA 76921	Aurobindo	18	Marketed
Jun 28, 2005	MirtazapineANDA 76901	Impax Labs Inc	10	Discontinued
Aug 31, 2005	MirtazapineANDA 76689	Actavis Elizabeth	1	Discontinued
Feb 28, 2006	MirtazapineANDA 77376 · Labeling	Aurobindo Pharma	14	Marketed
Aug 22, 2007	MirtazapineANDA 77666	Apotex	10	Marketed
Feb 14, 2011	MirtazapineANDA 77959	Actavis Elizabeth	0	Discontinued
Jun 1, 2017	MirtazapineANDA 205798	Square Pharms PLC	2	Marketed
Jan 18, 2023	MirtazapineANDA 216751	Prasco	1	Marketed
Oct 2, 2025	MirtazapineANDA 219721	Annora Pharma	0	Marketed
Feb 2, 2026	MirtazapineANDA 219919	Novitium Pharma	0	Marketed
May 19, 2026	MirtazapineANDA 220104	Micro Labs	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