Fusidic acid

Overview

An antibiotic isolated from the fermentation broth of Fusidium coccineum. (From Merck Index, 11th ed) It acts by inhibiting translocation during protein synthesis. It is often used topically in creams and eyedrops but is available in systemic formulations including tablets and injections.

Indication

For the treatment of bacterial infections.

Associated Conditions

Bacterial Conjunctivitis
Eye and eyelid infections
Fungal skin infection
Skin Infections caused by Corynebacterium minutissimum infection
Skin Infections caused by Staphylococcus Aureus
Skin Infections caused by Streptococcus Infection
Stye
Bacterial skin infections
Cutaneous dermatophyte infection
Eczematous rash
Mild Atopic dermatitis
Mild Dermatitis caused by Staphylococcus aureusis
Moderate Atopic dermatitis
Moderate Dermatitis caused by Staphylococcus aureusis
Ocular bacterial infections
Susceptible Bacterial Infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia	2024/11/19	NCT06695143	Phase 3	Not yet recruiting	Institute of Tropical Medicine, Belgium
Study to Determine the Efficacy&Safety of ARV-1801(ACG-701) for the Treatment of Cystic Fibrosis Pulmonary Exacerbations	2022/12/07	NCT05641298	Phase 2	Withdrawn	Aceragen
Oral ARV-1801 Given in Combination With Intravenous Ceftazidime or Meropenem for Treatment of Melioidosis in Hospitalized Patients	2021/11/03	NCT05105035	Phase 2	Completed	Arrevus Inc.
S. Aureus Decolonization in HPN Patients.	2017/06/01	NCT03173053	Not Applicable	Terminated	Radboud University Medical Center
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections	2015/10/07	NCT02570490	Phase 3	Completed	Arrevus Inc.
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections	2015/10/06	NCT02569541	Phase 2	Completed	Arrevus Inc.
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection	2012/12/28	NCT01756924	Phase 2	Terminated	Arrevus Inc.
Scars After Central Venous Catheters	2010/04/29	NCT01113125	Phase 3	UNKNOWN	Mette Møller Handrup
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections	2009/07/29	NCT00948142	Phase 2	Completed	Arrevus Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
FUCIDIN H CREAM	LEO Laboratories Limited	SIN10834P	CREAM	20 mg/g	3/24/1999
FOBAN CREAM 2% w/w	HOE PHARMACEUTICALS SDN BHD	SIN11036P	CREAM	2% w/w	7/20/1999
DISUF OINTMENT 2% W/W	Hovid Bhd.	SIN14054P	OINTMENT	2.04% w/w	11/22/2011
FORSUDERM OINTMENT 20 mg/g	PHARMGEN SCIENCE INC.	SIN10706P	OINTMENT	20 mg/g	1/25/1999
DUZEN CREAM 2% w/w	PRIME PHARMACEUTICAL SDN BHD	SIN12595P	CREAM	2% w/w	10/4/2004
FUCIDIN OINTMENT 2%	LEO LABORATORIES LIMITED	SIN00722P	OINTMENT	20 mg/g	5/4/1988
AXCEL FUSIDIC ACID CREAM 2.0% w/w	KOTRA PHARMA (M) SDN BHD	SIN14677P	CREAM	20 mg/g	11/24/2014
FUSTADIN CREAM 2%W/W	Y.S.P. Industries (M) Sdn. Bhd.	SIN15567P	CREAM	20mg/g	10/24/2018
FUSIDIC ACID "PBF" CREAM 20MG/G	PANION & BF BIOTECH INC., PINGJHEN PLANT	SIN15868P	CREAM	20mg/g	12/4/2019
DEFUZIN CREAM 2% W/W	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN15620P	CREAM	2.00% w/w	2/1/2019

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
FOBAN CREAM 2%	N/A	TAISHO PHARMACEUTICAL (H.K.) LIMITED	N/A	N/A	9/29/2000
FUSOTEX CREAM 2%	N/A	HITPHARM PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	2/26/2010
FUSKINS CREAM 2% W/W	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	5/4/2017

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FUCIDIN sodium fusidate 250 mg tablet blister pack	125822	LEO Pharma Pty Ltd	Medicine	A	1/31/2007
FUCIDIN sodium fusidate 20mg/g ointment tube	12990	LEO Pharma Pty Ltd	Medicine	A	8/14/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FUCIDIN INTERTULLE 2%	LEO Pharma Inc	00586684	Dressing - Topical	2 %	12/31/1984
FUCITHALMIC	Amdipharm Limited	02243861	Drops - Ophthalmic	1 % / W/W	8/7/2001
FUCIDIN LEO INJECTION KIT	LEO Pharma Inc	02049406	Kit - Intravenous	500 MG / KIT	12/31/1984
FUCIDIN FILM COATED TAB 250MG	LEO Pharma Inc	01934252	Tablet - Oral	250 MG	12/31/1991
FUCIDIN LEO SUS 246MG/5ML	LEO Pharma Inc	00506036	Suspension - Oral	246 MG / 5 ML	12/31/1980
FUCIDIN CREAM 2%	LEO Pharma Inc	00586668	Cream - Topical	2 %	12/31/1984
FUCIDIN OINTMENT 2%	LEO Pharma Inc	00586676	Ointment - Topical	2 %	12/31/1984
FUCIBET	LEO Pharma Inc	02474883	Cream - Topical	2 % / W/W	10/3/2018
FUCITHALMIC	Amdipharm Limited	02243862	Drops - Ophthalmic	1 % / W/W	8/29/2001
FUCIDIN H	LEO Pharma Inc	02238578	Cream - Topical	2 %	11/11/1998

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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