MedPath

Fluvoxamine

Generic Name
Fluvoxamine
Brand Names
Luvox
Drug Type
Small Molecule
Chemical Formula
C15H21F3N2O2
CAS Number
54739-18-3
Unique Ingredient Identifier
O4L1XPO44W

Overview

Fluvoxamine is an antidepressant which functions pharmacologically as a selective serotonin reuptake inhibitor. Though it is in the same class as other SSRI drugs, it is most often used to treat obsessive-compulsive disorder. Fluvoxamine has been in use in clinical practice since 1983 and has a clinical trial database comprised of approximately 35,000 patients. It was launched in the US in December 1994 and in Japan in June 1999. As of the end of 1995, more than 10 million patients worldwide have been treated with fluvoxamine.

Indication

Indicated predominantly for the management of depression and for Obsessive Compulsive Disorder (OCD) . Has also been used in the management of bulimia nervosa .

Associated Conditions

  • Bulimia Nervosa
  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/13
Phase 3
Not yet recruiting
2025/02/12
Phase 1
Recruiting
2024/01/30
Phase 1
Completed
Asceneuron S.A.
2023/11/13
Phase 3
Recruiting
Cardresearch
2023/06/08
Phase 3
Completed
Susanna Naggie, MD
2023/06/06
Phase 3
Completed
Susanna Naggie, MD
2023/06/05
Phase 1
Completed
2023/05/24
Phase 2
Active, not recruiting
2023/02/03
Phase 1
Completed
2022/09/08
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Actavis Pharma, Inc.
0228-2848
ORAL
100 mg in 1 1
10/13/2023
Preferred Pharmaceuticals Inc.
68788-8175
ORAL
100 mg in 1 1
6/14/2023
REMEDYREPACK INC.
70518-1057
ORAL
100 mg in 1 1
2/14/2024
A-S Medication Solutions
50090-5988
ORAL
100 mg in 1 1
7/31/2021
Bryant Ranch Prepack
71335-2008
ORAL
100 mg in 1 1
11/30/2021
Par Pharmaceutical, Inc.
10370-175
ORAL
100 mg in 1 1
10/12/2023
Bryant Ranch Prepack
71335-1974
ORAL
50 mg in 1 1
11/30/2021
Bryant Ranch Prepack
63629-8018
ORAL
25 mg in 1 1
7/7/2021
Upsher-Smith Laboratories, LLC
0832-1670
ORAL
25 mg in 1 1
8/31/2023
Apotex Corp
60505-0166
ORAL
100 mg in 1 1
2/13/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FAVERIN TABLET 100 mg (WHITE)
SIN09491P
TABLET, FILM COATED
100 mg
9/3/1997
APO-FLUVOXAMINE 100MG TABLET
SIN13559P
TABLET, FILM COATED
100 mg
10/7/2008
FLUVOXAMINE MALEATE TABLET 50 mg
SIN11823P
TABLET, FILM COATED
50 mg
2/26/2002
FAVERIN TABLET 50 mg (WHITE)
SIN09489P
TABLET, FILM COATED
50 mg
9/3/1997

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
RIVA-FLUVOX
laboratoire riva inc.
02303345
Tablet - Oral
50 MG
6/11/2008
PMS-FLUVOXAMINE
02240682
Tablet - Oral
50 MG
9/2/1999
RIVA-FLUVOX 50MG TABLETS
laboratoire riva inc.
02240723
Tablet - Oral
50 MG / TAB
8/27/1999
NOVO-FLUVOXAMINE
teva canada limited
02239954
Tablet - Oral
100 MG
4/30/1999
FLUVOXAMINE
02231193
Tablet - Oral
100 MG
N/A
FLUVOXAMINE-100
PRO DOC LIMITEE
02236754
Tablet - Oral
100 MG
4/10/1998
DOM-FLUVOXAMINE
dominion pharmacal
02241347
Tablet - Oral
50 MG
2/23/2000
AVA-FLUVOXAMINE
avanstra inc
02363771
Tablet - Oral
100 MG
8/22/2011
LUVOX
BGP Pharma ULC
01919342
Tablet - Oral
50 MG
12/31/1991
RIVA-FLUVOX 100MG TABLETS
laboratoire riva inc.
02240724
Tablet - Oral
100 MG / TAB
8/27/1999

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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