Malathion

Overview

Malathion is a parasympathomimetic organophosphate compound that is used as an insecticide for the treatment of head lice. Malathion is an irreversible cholinesterase inhibitor and has low human toxicity.

Indication

For patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

Associated Conditions

Head Lice Infestation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands	2017/08/01	NCT03236168	Phase 3	Completed	London School of Hygiene and Tropical Medicine
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	2009/08/21	NCT00963508	Phase 3	Completed	Taro Pharmaceuticals USA
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	2009/06/25	NCT00927472	Phase 3	Completed	Taro Pharmaceuticals USA
Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice	2009/06/25	NCT00927407	Phase 1	Completed	Taro Pharmaceuticals USA
Ivermectin in the Treatment of Head Lice	2009/01/09	NCT00819520	Phase 3	Completed	Johnson & Johnson Consumer and Personal Products Worldwide
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice	2005/10/26	NCT00244439	Phase 3	Completed	Taro Pharmaceuticals USA

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Malathion	Taro Pharmaceuticals U.S.A., Inc.	51672-5294	TOPICAL	0.0005 g in 1 mL	7/20/2018
Ovide	Taro Pharmaceuticals U.S.A., Inc.	51672-5293	TOPICAL	0.0005 g in 1 mL	7/20/2018
Malathion	Suven Pharmaceuticals Limited	68022-0001	TOPICAL	0.005 g in 1 mL	1/9/2024

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
LICE CARE LOTION 0.5% w/v	ICM PHARMA PTE. LTD.	SIN09320P	EMULSION	0.5% w/v	5/2/1997

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
K.P. 24 MEDICATED FOAM malathion 1% application bottle (reformulation)	116798	Pharmacare Laboratories Pty Ltd	Medicine	A	2/24/2005
K.P. 24 MEDICATED LOTION malathion 0.5% topical solution bottle (reformulation)	116787	Pharmacare Laboratories Pty Ltd	Medicine	A	2/22/2005

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