TheraRadar
Data updated: May 26, 2026

CROTAN (crotamiton)

Dermatology Approved 1981-12-16

CROTAN is indicated for the treatment of Scabies; Pruritus.

Source: FDA Label • LEGACY PHARMA
1
Indication
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1981-12-16
Routes
TOPICAL
Dosage Forms
LOTION

Companies

Active Ingredient: CROTAMITON

CROTAN Approval History

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Original
New Indication
New Form
Label Update
4 FDA actions from 1981 to 2014
Mar 2014 SUPPL
Label · Labeling
Nov 1994 SUPPL
Label · Labeling
Feb 1992 SUPPL
Label · Labeling

What CROTAN Treats

2 indications

CROTAN is approved for 2 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Scabies
  • Pruritus
Source: FDA Label

CROTAN Competitive Set

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Drugs Similar to CROTAN

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BYLVAY
ODEVIXIBAT
1 shared
IPSEN
Shared indications:
Pruritus
ELIMITE
PERMETHRIN
1 shared
Aurobindo Pharma
Shared indications:
Scabies
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
1 shared
Novartis
Shared indications:
Pruritus
🔬

Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CROTAN FDA Label Details

Indications & Usage

CROTAN is indicated for the treatment of Scabies; Pruritus.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.