Biotin

Overview

A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.

Indication

For nutritional supplementation, also for treating dietary shortage or imbalance.

Associated Conditions

Vitamin Deficiency

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma	2022/11/30	NCT05632549	Phase 3	Active, not recruiting	Tanta University
Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease	2020/07/20	NCT04476277	Early Phase 1	Completed	National Heart, Lung, and Blood Institute (NHLBI)
Red Blood Cell Survival in Sickle Cell Disease	2020/06/11	NCT04426591	Phase 1	Completed	Marianne Yee
Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis	2018/06/11	NCT03552211	N/A	UNKNOWN	University Hospital, Clermont-Ferrand
Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis	2018/02/09	NCT03427086	Phase 2	Completed	American University of Beirut Medical Center
RBC Lifespan Measurement in Diabetic Children	2017/03/08	NCT03073070	Phase 1	Completed	Guohua An
BioRBC Survival in Adults With Prior Antibody Response to BioRBCs	2014/03/04	NCT02077751	Phase 1	Completed	John A Widness
Mechanisms Accounting for Unexplained Anemia in the Elderly	2012/04/06	NCT01572506	Phase 1	Completed	National Institute on Aging (NIA)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
5% Minoxidil Hair Growth Sprays Serum	Shenzhen Joyuflsh Technology Co.,Ltd.	83766-106	TOPICAL	0.5 g in 100 mL	5/26/2025
BACMIN	Marnel Pharmaceuticals, Inc.	0682-3001	ORAL	150 ug in 1 1	5/2/2014
Floriva	BonGeo Pharmaceuticals, Inc.	52796-174	ORAL	40 ug in 1 1	2/2/2024
Pediatric Infuvite Multiple Vitamins	Sandoz Inc	54643-9023	INTRAVENOUS	20 ug in 5 mL	10/28/2016
Adult Infuvite Multiple Vitamins	Sandoz Inc	54643-9015	INTRAVENOUS	60 ug in 10 mL	10/28/2016
Koi Beauty 5% Minoxidil Hair Growth Kit	Beijing Sea Heart International Science And Technology Co.,Ltd.	85709-002	TOPICAL	0.3 mg in 100 mL	7/31/2025
NewVite	Trivia Pharmaceuticals, LLC	84781-012	ORAL	30 ug in 1 1	6/23/2025
Prenate Essential	Avion Pharmaceuticals, LLC	75854-313	ORAL	280 ug in 1 1	1/7/2021
Dialyvite Supreme D	Hillestad Pharmaceuticals USA	10542-009	ORAL	300 ug in 1 1	10/24/2019
RENO CAPS	Carilion Materials Management	68151-1928	ORAL	150 ug in 1 1	11/11/2013

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
TAMIPOOL FOR INJECTION	CELLTRION PHARM, INC.	SIN11849P	INJECTION, POWDER, FOR SOLUTION	60 mcg/vial	3/15/2002
CERNEVIT FOR INJECTION	FAREVA PAU 1 (Sub-contractor), Baxter S.A.	SIN11975P	INJECTION, POWDER, FOR SOLUTION	0.069 mg/vial	6/5/2002
SOLUVIT N FOR INFUSION	Fresenius Kabi SSPC	SIN05209P	INJECTION, POWDER, FOR SOLUTION	60 mcg/vial	11/14/1990

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
CERNEVIT FOR INJ	N/A	Baxter Healthcare Ltd	N/A	N/A	4/18/2008
BIHAKU TAB	N/A	SATO PHARMACEUTICAL CO.,LTD.	N/A	N/A	7/1/1994
HUAZIN INJ	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	4/28/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Energy Multi	453128	Australian Pharmaceutical Industries Pty Ltd	Medicine	A	6/21/2024
Cellula-T oral powder jar	43995	Hong Sp & Hs	Medicine	A	4/13/1993
BLACKMORES SUPERKIDS MULTI CHEWABLES	289492	Blackmores Ltd	Medicine	A	5/30/2017
Super B Complex tablets	126510	Sphere Healthcare Pty Ltd	Medicine	A	3/28/2006
MaxN-Fuze Multivitamins	288444	Max Health & Living Australia Pty Ltd	Medicine	A	5/1/2017
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs	139048	Universal Pharmaceuticals Pty Ltd	Medicine	A	5/21/2007
Caruso's Hair Food	130857	Caruso's Natural Health Pty Ltd	Medicine	A	8/30/2006
Berocca Performance Original effervescent tablets	193893	Bayer Australia Ltd	Medicine	A	1/17/2012
Threshold Controlled B-Complex	276600	NeoLife International Pty Ltd	Medicine	A	6/15/2016
Men's Multi	326959	Good Health Products Australia	Medicine	A	12/2/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
STRESS B CAPSULES WITH VITAMIN C	rheingold food international ltd.	00694509	Capsule - Oral	25 MCG / CAP	12/31/1987
CENTURY PLUS	vita health products inc	N/A	Tablet - Oral	45 MCG / TAB	2/5/1998
STRESS B PLUS VITAMINS & MINERALS	great earth companies, inc.	02231749	Tablet (Extended-Release) - Oral	160 MCG / TAB	9/25/1998
STRESS B WITH 1000 MG VITAMIN C	holista health (canada) inc.	02246252	Tablet - Oral	25 MCG	11/13/2002
MATERNITY ONE MULTIVITAMIN WITH MINS CAPLET	swiss herbal remedies ltd.	01918052	Tablet - Oral	100 MCG	12/31/1991
POLYMINE AVEC ZINC ET CUIVRE	les laboratoires vachon inc.	00630888	Tablet - Oral	45 MCG	12/31/1985
MULTIVITAMINS AND MINERALS - FORTE	vita health products inc	02239947	Tablet - Oral	45 MCG / TAB	2/1/2000
MULTI-REGIME	regime industries ltd.	02247272	Capsule - Oral	50 MCG	6/16/2003
STRESS B COMPLEX WITH C AND E TAB	PHARMAVITE LLC	02008947	Tablet - Oral	45 MCG / TAB	12/31/1993
LIQUI B COMPLEX PLUS	twin laboratories inc.	01984411	Liquid - Oral	30 MCG / ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
BECOZYME C FORTE COMPRIMIDOS RECUBIERTOS	Bayer Hispania S.L.	40869	COMPRIMIDO RECUBIERTO	Sin Receta	Commercialized
CERNEVIT POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Baxter S.L.	60022	LIOFILIZADO PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Hispania S.L.	67267	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Not Commercialized
VIANT POLVO PARA SOLUCION PARA PERFUSION	B. Braun Melsungen Ag	83664	POLVO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES	Laboratorios Menarini S.A.	44019	COMPRIMIDO MASTICABLE	Sin Receta	Not Commercialized
MEDEBIOTIN FUERTE SOLUCION INYECTABLE	Laboratorio Reig Jofre, S.A.	34236	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
MEDEBIOTIN FUERTE COMPRIMIDOS	Laboratorio Reig Jofre, S.A.	24616	COMPRIMIDO	Sin Receta	Commercialized
SOLUVIT LIOFILIZADO PARA SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	61228	POLVO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
HIDROPOLIVIT GOTAS ORALES EN SOLUCION	Laboratorios Menarini S.A.	44000	GOTAS ORALES EN SOLUCIÓN	Sin Receta	Commercialized

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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