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.
Background
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 |
|---|---|---|---|---|---|
| Fluvoxamine Maleate Tablets | 国药准字H20249819 | 化学药品 | 片剂 | 12/25/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20253471 | 化学药品 | 片剂 | 2/25/2025 | |
| Fluvoxamine Maleate Tablets | 国药准字H20244601 | 化学药品 | 片剂 | 7/30/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20244559 | 化学药品 | 片剂 | 7/30/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20058921 | 化学药品 | 片剂 | 4/21/2020 | |
| Fluvoxamine Maleate Tablets | 国药准字H20249544 | 化学药品 | 片剂 | 12/1/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20249543 | 化学药品 | 片剂 | 12/1/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20249500 | 化学药品 | 片剂 | 12/1/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字H20249611 | 化学药品 | 片剂 | 12/1/2024 | |
| Fluvoxamine Maleate Tablets | 国药准字HJ20181117 | 化学药品 | 片剂 | 10/18/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Fluvoxamine-WGR fluvoxamine maleate 100 mg tablet blister pack | 147397 | Medicine | A | 1/14/2009 | |
| LUVOX fluvoxamine maleate 50mg tablet blister pack | 57632 | Medicine | A | 4/1/1997 | |
| LUVOX fluvoxamine maleate 100mg tablet blister pack | 57633 | Medicine | A | 4/1/1997 | |
| Fluvoxamine-WGR fluvoxamine maleate 50 mg tablet blister pack | 147396 | Medicine | A | 1/14/2009 | |
| APO-FLUVOXAMINE fluvoxamine maleate 50 mg tablet blister pack | 147380 | Medicine | A | 1/14/2009 | |
| MOVOX fluvoxamine maleate 100mg tablet blister pack | 90059 | Medicine | A | 7/29/2002 | |
| MOVOX fluvoxamine maleate 50mg tablet blister pack | 90058 | Medicine | A | 7/29/2002 | |
| APO-FLUVOXAMINE fluvoxamine maleate 100 mg tablet blister pack | 147389 | Medicine | A | 1/14/2009 | |
| FAVERIN fluvoxamine maleate 100mg tablet blister pack | 64388 | Medicine | A | 5/27/1998 | |
| FAVERIN 50 fluvoxamine maleate 50mg tablet blister pack | 90057 | Medicine | A | 7/12/2002 |