Overview
Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as flavin mononucleotide and flavin-adenine dinucleotide.
Background
Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as flavin mononucleotide and flavin-adenine dinucleotide.
Indication
For the treatment of ariboflavinosis (vitamin B2 deficiency).
Associated Conditions
- Ariboflavinosis
- Beriberi
- Constipation
- Functional Gastrointestinal Disorders (FGID)
- Joint Pain
- Metabolic cardiomyopathy
- Migraine
- Myalgia
- Neuropathic Pain
- Peripheral neuritis
- Peripheral paralysis
- Vitamin B complex deficiency
- Vitamin B1 deficiency
- Vitamin Deficiency
- Wernicke's encephalopathy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/18 | Early Phase 1 | Completed | Steven Moore | ||
2023/05/31 | Not Applicable | Not yet recruiting | |||
2021/08/30 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/05/27 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/05/21 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/02/01 | Early Phase 1 | Not yet recruiting | Kent Wellish MD | ||
2020/10/12 | Not Applicable | Not yet recruiting | Joseph B. Ciolino, MD | ||
2020/06/11 | Phase 4 | Completed | |||
2020/01/18 | Phase 2 | UNKNOWN | |||
2019/09/20 | Phase 3 | Completed | Thomas M. Lietman |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvPAK | 50268-677 | ORAL | 3 mg in 1 1 | 4/12/2022 | |
| CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 1.3 mg in 1 1 | 1/10/2024 | |
| Method Pharmaceuticals, LLC | 58657-164 | ORAL | 1.2 mg in 1 1 | 12/9/2023 | |
| Exeltis USA, Inc. | 0642-7473 | ORAL | 1.8 mg in 1 1 | 2/14/2023 | |
| Marnel Pharmaceuticals, Inc. | 0682-3001 | ORAL | 20 mg in 1 1 | 5/2/2014 | |
| Centurion Labs, LLC | 23359-105 | ORAL | 3 mg in 1 1 | 1/22/2024 | |
| PureTek Corporation | 59088-193 | ORAL | 3.4 mg in 1 1 | 1/11/2023 | |
| BonGeo Pharmaceuticals, Inc. | 52796-174 | ORAL | 1.5 mg in 1 1 | 2/2/2024 | |
| Cameron Pharmaceuticals | 42494-432 | ORAL | 1.2 mg in 1 1 | 9/18/2023 | |
| Carilion Materials Management | 68151-2640 | ORAL | 3 mg in 1 1 | 4/1/2013 |
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 |
|---|---|---|---|---|---|
| ENZYPLEX TABLET | SIN06211P | ENTERIC COATED TABLET | 5 mg | 5/3/1991 | |
| IBERET-FOLIC-500 TABLET | SIN05447P | TABLET, FILM COATED | 6 mg | 2/19/1991 | |
| FBC FILMTAB | SIN05814P | TABLET, FILM COATED | 2 mg | 5/3/1991 | |
| CERNEVIT FOR INJECTION | SIN11975P | INJECTION, POWDER, FOR SOLUTION | 4.14 mg/vial | 6/5/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Vitamin B2 Tablets | 国药准字H12020169 | 化学药品 | 片剂 | 8/13/2020 | |
| Vitamin B2 Tablets | 国药准字H22020790 | 化学药品 | 片剂 | 10/10/2020 | |
| Vitamin B2 Tablets | 国药准字H46020369 | 化学药品 | 片剂 | 3/26/2020 | |
| Vitamin B2 Tablets | 国药准字H44022759 | 化学药品 | 片剂 | 1/11/2021 | |
| Vitamin B2 Tablets | 国药准字H14022479 | 化学药品 | 片剂 | 8/18/2020 | |
| Vitamin B2 Tablets | 国药准字H61022321 | 化学药品 | 片剂 | 7/14/2022 | |
| Vitamin B2 Tablets | 国药准字H36021088 | 化学药品 | 片剂 | 7/14/2021 | |
| Vitamin B2 Tablets | 国药准字H34021622 | 化学药品 | 片剂 | 6/2/2020 | |
| Vitamin B2 Tablets | 国药准字H61020800 | 化学药品 | 片剂 | 5/28/2020 | |
| Vitamin B2 Tablets | 国药准字H44021854 | 化学药品 | 片剂 | 11/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MULTIMAX SYRUP | N/A | vickmans laboratories ltd | N/A | N/A | 7/8/2014 |
| CERNEVIT FOR INJ | N/A | N/A | N/A | 4/18/2008 | |
| BIOCATALIN INJECTABLE SOLN (VET) | N/A | wai lung hong agribusiness ltd | N/A | N/A | 8/9/1984 |
| CHLORAFORTE CAP | N/A | meyer pharmaceuticals ltd | N/A | N/A | 6/2/1992 |
| BIHAKU TAB | N/A | sato pharmaceutical (hk) co ltd | N/A | N/A | 7/1/1994 |
| BOGEN-50 S C TAB | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 4/28/1982 |
| HUAZIN INJ | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 4/28/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Energy Multi | 453128 | Medicine | A | 6/21/2024 | |
| Cellula-T oral powder jar | 43995 | Hong Sp & Hs | Medicine | A | 4/13/1993 |
| Men's Multi | 326959 | Medicine | A | 12/2/2019 | |
| Super B Complex tablets | 126510 | Medicine | A | 3/28/2006 | |
| BLACKMORES SUPERKIDS MULTI CHEWABLES | 289492 | Medicine | A | 5/30/2017 | |
| BLACKMORES B+C TABLETS | 215811 | Medicine | A | 10/9/2013 | |
| Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs | 139048 | Medicine | A | 5/21/2007 | |
| Caruso's Hair Food | 130857 | Medicine | A | 8/30/2006 | |
| MaxN-Fuze Multivitamins | 288444 | Max Health & Living Australia Pty Ltd | Medicine | A | 5/1/2017 |
| Berocca Performance Original effervescent tablets | 193893 | Medicine | A | 1/17/2012 |