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fluvoxamine

Generic: FLUVOXAMINE MALEATE·Brand: FLUVOXAMINE MALEATE, LUVOX, LUVOX CR

fluvoxamine: developed by 2 companies · 2 clinical trials tracked · 2 FDA decisions.

fluvoxamine evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about fluvoxamine, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence0 indications · 1 study sponsors

Related indications

No linked indication is available.

Development Pipeline (2)
CompanyPhase
ANI PHARMACEUTICALS INC (ANIP)Approved
Jazz Pharmaceuticals plc (JAZZ)Approved
Clinical Trials (2)

COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)

NCT04510194·Phase 3
Completed

Primary endpoint: Clinical Progression to Severe Covid

InterventionalRandomizedquadruple1,323 enrolledStarted 2021-01Completion 2022-127 sites · United StatesUniversity of Minnesota

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

NCT03511118·N/A·INSM
Recruiting

Primary endpoint: M/P ratio

Observational1,600 targetStarted 2018-10Completion 2027-0722 sites · Canada, United StatesDuke University
FDA Decisions2 records
Approval(JAZZ)FDA ↗
NDA022235Type 6 - New Indication (no longer used)StandardOralTablet
Approval1 INDICATIONS AND USAGE Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social o(ANIP)FDA ↗
NDA021519Type 3 - New Dosage FormStandardOralTablet

Frequently asked questions

Who is developing fluvoxamine?

fluvoxamine is being developed by ANI PHARMACEUTICALS INC, Jazz Pharmaceuticals plc.

How many clinical trials involve fluvoxamine?

BioSniper tracks 2 clinical trials involving fluvoxamine.

What is fluvoxamine's latest FDA decision?

The most recent tracked FDA decision for fluvoxamine is Approval, dated April 14, 2008.