Overview
Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .
Background
Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .
Indication
Nasal spray The cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement . Note: CaloMist , the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency. Injection forms (subcutaneous, intramuscular) These forms are indicated for vitamin B12 deficiencies due to various causes, with or without neurologic manifestations . Vitamin B12 deficiency is frequently caused by malabsorption, which is often associated with the following conditions : Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of the pancreas or bowel Folic acid deficiency Oral forms Vitamin B12 supplements are widely available and indicated in patients who require supplementation for various reasons. Dose requirements for vitamin B12 which are higher than normal (caused by pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be achieved with oral supplementation . Oral products of vitamin B12 are not recommended in patients with malabsorption, as these forms are primarily absorbed in the gastrointestinal tract .
Associated Conditions
- Neuritis
- Vitamin Deficiency
- Vitamin B6 Deficiency
- Diabetic Neuropathies
- Vitamin B1 deficiency
- Anemia, Pernicious
- Vitamin B12 Deficiency
- Convalescence
- Iron Deficiency Anemia (IDA)
- Folate deficiency
- Combined Vitamin B1 and B12 deficiency
- Vitamin B12 concentration
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/25 | N/A | Completed | OZGUR EKICI | ||
2023/07/24 | Phase 3 | Completed | KRL Hospital, Islamabad | ||
2022/03/22 | Phase 1 | Completed | |||
2022/02/03 | Phase 4 | Completed | |||
2020/05/13 | Phase 4 | Completed | |||
2019/01/14 | Not Applicable | Withdrawn | |||
2018/12/31 | Phase 2 | UNKNOWN | Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara | ||
2018/02/19 | Early Phase 1 | Completed | |||
2017/04/05 | Phase 1 | Completed | |||
2016/05/16 | Phase 2 | UNKNOWN | Göteborg University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AvPAK | 50268-677 | ORAL | 12 ug in 1 1 | 4/12/2022 | |
IT3 Medical LLC | 70529-293 | INTRAMUSCULAR, SUBCUTANEOUS | 1000 ug in 1 mL | 8/17/2018 | |
CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 4 ug in 1 1 | 1/10/2024 | |
Mission Pharmacal Company | 0178-0813 | ORAL | 16.8 ug in 1 1 | 1/5/2024 | |
Method Pharmaceuticals, LLC | 58657-164 | ORAL | 4.5 ug in 1 1 | 12/9/2023 | |
Avion Pharmaceuticals, LLC | 75854-344 | ORAL | 25 ug in 1 1 | 4/8/2025 | |
Exeltis USA, Inc. | 0642-7473 | ORAL | 25 ug in 1 1 | 2/14/2023 | |
Marnel Pharmaceuticals, Inc. | 0682-3001 | ORAL | 50 ug in 1 1 | 5/2/2014 | |
Centurion Labs, LLC | 23359-105 | ORAL | 15 ug in 1 1 | 1/22/2024 | |
Avion Pharmaceuticals, LLC | 75854-320 | ORAL | 10 ug in 1 1 | 1/18/2021 |
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 |
---|---|---|---|---|---|
VITAMIN B12 INJECTION 1000 mcg/ml | ATLANTIC LABORATORIES CORPN LTD | SIN07876P | INJECTION | 1000 mcg/ml | 10/20/1994 |
DANEURON TABLET | SIN12077P | TABLET, FILM COATED | 200 mcg | 9/17/2002 | |
NUTRIHEALTH NEUROVIT FORTE TABLET | SIN10260P | TABLET, FILM COATED | 1.0 mg | 10/14/1998 | |
NUTRIHEALTH NEUROVIT TABLET | SIN10261P | TABLET, FILM COATED | 100 mcg | 10/14/1998 | |
ENZYPLEX TABLET | SIN06211P | ENTERIC COATED TABLET | 5 mcg | 5/3/1991 | |
NEUROBION TABLET | SIN06258P | TABLET, SUGAR COATED | 200 mcg | 6/21/1991 | |
NEUROBION INJECTION | SIN06262P | INJECTION | 1 mg/3 ml | 6/21/1991 | |
VITAMIN B FORTE TABLET | SIN07635P | TABLET, FILM COATED | 1000 mcg | 2/4/1994 | |
FBC FILMTAB | SIN05814P | TABLET, FILM COATED | 5 mcg | 5/3/1991 | |
TAMIPOOL FOR INJECTION | SIN11849P | INJECTION, POWDER, FOR SOLUTION | 5 mcg/vial | 3/15/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Vitamin B12 Solution | 国药准字H10940197 | 化学药品 | 溶液剂 | 8/21/2020 | |
Vitamin B12 Injection | 国药准字H44022068 | 化学药品 | 注射剂 | 7/30/2020 | |
Vitamin B12 Injection | 国药准字H37022955 | 化学药品 | 注射剂 | 7/25/2023 | |
Vitamin B12 Injection | 国药准字H44022100 | 化学药品 | 注射剂 | 3/10/2020 | |
Vitamin B12 Injection | 国药准字H43021482 | 化学药品 | 注射剂 | 8/4/2020 | |
Vitamin B12 Injection | 国药准字H37021054 | 化学药品 | 注射剂 | 5/8/2020 | |
Vitamin B12 Injection | 国药准字H44022524 | 化学药品 | 注射剂 | 1/6/2020 | |
Vitamin B12 Injection | 国药准字H41020634 | 化学药品 | 注射剂 | 1/8/2020 | |
Vitamin B12 Injection | 国药准字H45020962 | 化学药品 | 注射剂 | 9/29/2020 | |
Vitamin B12 Injection | 国药准字H53021284 | 化学药品 | 注射剂 | 9/28/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
NEW-PAIN-Q CAP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 6/20/1990 |
SUMITON CAPSULE (NEW FORMULA) | N/A | europharm lab co ltd | N/A | N/A | 6/17/2014 |
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 |
TELING EYE DROPS | N/A | sato pharmaceutical (hk) co ltd | N/A | N/A | 12/8/1992 |
NOARL ONE N EYE DROPS | N/A | sato pharmaceutical (hk) co ltd | N/A | N/A | 12/5/2001 |
WHARNIS (NEW FORMULA) CAPSULES | N/A | europharm lab co ltd | N/A | N/A | 11/29/2013 |
HEPATOSWISS FOR IV INFUSION INJ | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 11/12/1982 |
HEPATOSWISS IM INJ | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 8/13/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Cellula-T oral powder jar | 43995 | Hong Sp & Hs | Medicine | A | 4/13/1993 |
Caruso's St John's Wort | 286553 | Medicine | A | 3/9/2017 | |
BLACKMORES SUPERKIDS MULTI CHEWABLES | 289492 | Medicine | A | 5/30/2017 | |
Super B Complex tablets | 126510 | Medicine | A | 3/28/2006 | |
BLACKMORES B+C TABLETS | 215811 | Medicine | A | 10/9/2013 | |
MaxN-Fuze Multivitamins | 288444 | Max Health & Living Australia Pty Ltd | Medicine | A | 5/1/2017 |
Blackmores Bio Iron (NZ) | 143952 | Medicine | A | 8/29/2007 | |
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs | 139048 | Medicine | A | 5/21/2007 | |
Berocca Performance Original effervescent tablets | 193893 | Medicine | A | 1/17/2012 | |
Cenovis Iron Plus | 265482 | Medicine | A | 12/4/2015 |