MedPath

Lindane

Generic Name
Lindane
Drug Type
Small Molecule
Chemical Formula
C6H6Cl6
CAS Number
58-89-9
Unique Ingredient Identifier
59NEE7PCAB

Overview

An organochlorine insecticide that has been used as a pediculicide and a scabicide. Lindane has been banned in California, United Kingdom, Australia, and many western countries due to concerns about neurotoxicity and adverse effects on the environment. In Canada, Lindane is not recommmended as a first-line therapy due to reports of resistance, neurotoxicity, and bone marrow suppression, but has been approved by the FDA as a second-line therapy for topical treatment of pediculosis capitis (head lice), pediculosis pubis (pubic lice), or scabies in patients greater than two years of age who cannot tolerate or have failed first-line treatment. Lindane is still allowed for pharmaceutical use until 2015.

Indication

For the treatment of patients infested with Sarcoptes scabiei or pediculosis capitis who have either failed to respond to adequate doses, or are intolerant of other approved therapies.

Associated Conditions

  • Lice Infestations
  • Pediculosis Capitis
  • Scabies

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
VersaPharm Incorporated
61748-400
TOPICAL
10 mg in 1 mL
3/17/2009
Morton Grove Pharmaceuticals, Inc.
60432-834
TOPICAL
10 mg in 1 mL
12/30/2020

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
PMS-LINDANE LOTION 1%
N/A
N/A
N/A
1/21/2000

TGA Drug Approvals

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DOM-LINDANE LOTION - 1%
dominion pharmacal
02176971
Liquid - Topical
1 %
12/31/1995
LINDANE SHAMPOO USP 1%
national care products ltd.
01988166
Shampoo - Topical
1 %
12/31/1994
PMS-LINDANE LOT 1%
00703591
Lotion - Topical
1 %
12/31/1987
LINDANE LOTION USP 1%
national care products ltd.
01988174
Lotion - Topical
1 %
8/27/1996
KWELLADA LOTION 1%
reed & carnrick, division of block drug company (canada) ltd.
00026212
Lotion - Topical
1 %
12/31/1958
HEXIT SHAMPOO 1.0%
odan laboratories ltd
00430617
Shampoo - Topical
1 %
12/31/1989
KWELLADA SHAMPOO 1%
reed & carnrick, division of block drug company (canada) ltd.
00026220
Shampoo - Topical
1 %
12/31/1960
HEXIT LOTION
odan laboratories ltd
02245872
Lotion - Topical
1 %
7/15/2003
PMS-LINDANE SHP 1%
00703605
Shampoo - Topical
1 %
12/31/1987

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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