Retapamulin

Overview

Retapamulin, marketed by GlaxoSmithKline as the ointment Altabax, is an antibiotic for skin infections like impetigo. It was approved by the FDA in April 2007.

Indication

For use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Associated Conditions

Staphylococcal impetigo
Streptococcal impetigo

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Retapamulin as a Decolonizing Agent for MRSA	2017/10/09	NCT03304873	Phase 3	Completed	NYU Langone Health
Retapamulin Microdialysis Feasibility Study	2013/03/18	NCT01812382	Phase 1	Completed	GlaxoSmithKline
Treatment of Staphylococcus Aureus Colonization in Hand Eczema	2012/05/04	NCT01591785	Not Applicable	Completed	Gary Goldenberg
Retapamulin for Reducing MRSA Nasal Carriage	2011/10/28	NCT01461668	Phase 4	Completed	University of California, Irvine
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo	2011/07/19	NCT01397461	Phase 3	Completed	Ferrer Internacional S.A.
United States Pharmacovigilence Retapamulin-Prescribing	2010/06/30	NCT01153880	N/A	Completed	GlaxoSmithKline
EU PV for Retapamulin-Prescribing	2010/06/30	NCT01153828	N/A	Completed	GlaxoSmithKline
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection	2010/05/19	NCT01126268	Phase 4	Completed	The University of Texas Health Science Center, Houston
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis	2010/02/09	NCT01064947	Phase 4	Completed	Derm Research, PLLC
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery	2009/05/18	NCT00903279	Phase 2	Withdrawn	Bay Pines VA Healthcare System

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Altabax	Almirall, LLC	16110-518	TOPICAL	10 mg in 1 g	5/10/2018
Altabax	Physicians Total Care, Inc.	54868-6096	TOPICAL	10 mg in 1 g	1/13/2010
Altabax	Rebel Distributors Corp.	21695-644	TOPICAL	10 mg in 1 g	1/13/2010

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

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