Paroxetine Mesylate

Treats moderate to severe vasomotor symptoms (VMS) associated with menopause. Sold as Pexeva, Brisdelle. Every FDA application for this active ingredient: 2 branded and 2 generic.

As of Nov 15, 2026, FDA lists 4 applications for Paroxetine Mesylate (sold as Pexeva, Brisdelle), first approved Jul 3, 2003, with 3 new uses approved and 0 published complete response letters.

First approved: Jul 3, 2003
Applications: 4
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $495K

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Paroxetine Mesylate	Part D	$495K	-21%	994

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

PAROXETINE ER 12.5 MG TABLET: $0.482 per unitGeneric · -5% in a year
PAROXETINE ER 25 MG TABLET: $0.398 per unitGeneric · -21% in a year
PAROXETINE ER 37.5 MG TABLET: $0.439 per unitGeneric · -18% in a year
PAROXETINE HCL 10 MG TABLET: $0.063 per unitGeneric · -10% in a year
PAROXETINE HCL 10 MG/5 ML SUSP: $1.40 per MLGeneric · +4% in a year
PAROXETINE HCL 20 MG TABLET: $0.063 per unitGeneric · -12% in a year
PAROXETINE HCL 30 MG TABLET: $0.099 per unitGeneric · +3% in a year
PAROXETINE HCL 40 MG TABLET: $0.098 per unitGeneric · -10% in a year
PAROXETINE MESYLATE 7.5 MG CAP: $2.64 per unitGeneric · +4% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

PaxilDrugs with a new additional indication and a new dosage for the treatment of posttraumatic stress disorder. · GlaxoSmithKline K.K. · Nov 22, 2013
PaxilDrugs with a new additional indication and a new dosage for the treatment of social anxiety disorder. · GlaxoSmithKline K.K. · Oct 16, 2009

Clinical Trials

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


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
Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake InhibitorsDepression Disorder · Hôpital le Vinatier	Not applicable	Not yet recruiting	Jul 21, 2026
Antidepressant Therapy for Improved Blood Vessel Health After PreeclampsiaPreeclampsia, Endothelial Function · Anna Stanhewicz, PhD	Early phase 1	Recruiting	Jul 20, 2026
A Phase I Study of NS-079 in Healthy ParticipantsHealthy Adult Participants · NeuShen Therapeutics	Phase 1	Recruiting	Jun 25, 2026
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging MechanismsGeneralized Anxiety Disorder · Lishu Gao	Not applicable	Recruiting	Feb 6, 2026
Neurobiological and Genomic Predictors of Relapse in DepressionHealthy, Major Depressive Disorder (MDD) · Mehmet Kemal Arikan	—	Recruiting	Jan 9, 2026
Building Ukraine's Strength in PTSD Treatment and ResearchPost Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD · University of Luxembourg	Not applicable	Recruiting	Jan 5, 2026
Efficacy of Chronotherapeutic Combination for Major Depressive Episode With InsomniaMajor Depressive Disorder (MDD) With Insomnia · Assistance Publique - Hôpitaux de Paris	Phase 3	Recruiting	Aug 13, 2025

Applications

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


Jul 3, 2003	PexevaNDA 21299 · New active ingredient	Sebela Ireland Ltd	22	Discontinued
Jun 28, 2013	BrisdelleNDA 204516 · New dosage form	Legacy	9	Marketed
Jun 20, 2017	Paroxetine MesylateANDA 207139	Actavis Labs Fl Inc	2	Marketed
Aug 18, 2017	Paroxetine MesylateANDA 207188	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