NDAORALTABLET
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
3/8 — Basic
LUVOX (fluvoxamine maleate) by Sanofi is neurons. First approved in 1994.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUVOX (fluvoxamine maleate) is an oral selective serotonin reuptake inhibitor (SSRI) approved in 1994 for obsessive-compulsive disorder. It works by inhibiting the serotonin reuptake transporter in the brain, increasing serotonin availability at the synaptic level.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling contraction of brand team resources and shift toward generic transition planning.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.