NDAORALTABLET
Approved
Apr 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
LUVOX (fluvoxamine maleate) by Jazz Pharmaceuticals is neurons. Approved for obsessive compulsive disorder. First approved in 2008.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUVOX (fluvoxamine maleate) is an oral selective serotonin reuptake inhibitor (SSRI) approved for obsessive-compulsive disorder (OCD). It works by potently inhibiting the serotonin reuptake transporter in neurons, increasing serotonin availability in the synaptic space. The drug has been marketed since 2008 and is currently approaching loss of exclusivity.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30); brand team focus likely shifting toward retention strategies and cost management.
Mechanism of Action
neurons. Fluvoxamine has been shown to be a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo .
Indications (1)
Clinical Trials (13)
To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers
Started Feb 2025
38 enrolled
Healty Volunteers
Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects
Started Feb 2024
50 enrolled
Drug Drug Interaction
A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects
Started Jun 2023
16 enrolled
Healthy Male Subjects
A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers
Started Jul 2020
28 enrolled
Healthy Volunteer/DDI Study
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
Started Sep 2018
24 enrolled
Dermatitis, Atopic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.