DULOXETINE HYDROCHLORIDE

Post-LOE

duloxetine hydrochloride

Sunshine Biopharma
ANDAORALCAPSULE, DELAYED REL PELLETS
Approved
Feb 2021
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
6

Mechanism of Action

antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

Indications (4)

the following conditions: Major depressive disorder (MDD) in adults ( ) Generalized anxiety disorder (GAD) in adultsolder ( ) Diabetic peripheral neuropathic pain (DPNP) in adults ( ) Fibromyalgia (FM) in adultsolder ( ) Chronic musculoskeletal pain in adults ( )anxiety

Clinical Trials (5)

NCT03794154Phase 4Withdrawn

A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions

Started Mar 2020
0
Healthy
NCT03729284Phase 4Withdrawn

A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

Started Mar 2020
0
Healthy
NCT00122837Phase 3Completed

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Started Apr 2005
560 enrolled
Anxiety Disorder
NCT00122850Phase 3Completed

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Started Oct 2004
480 enrolled
Anxiety Disorders
NCT00042562Phase 3Completed

Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Started Dec 2002
Major Depressive Disorder
Company
Sunshine Biopharma
Sunshine Biopharma
QC - Varennes
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers