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Adapalene

Generic Name
Adapalene
Brand Names
Cabtreo, Differin, Epiduo, Panoxyl, Tactupump
Drug Type
Small Molecule
Chemical Formula
C28H28O3
CAS Number
106685-40-9
Unique Ingredient Identifier
1L4806J2QF

Overview

Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne. Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.

Background

Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne. Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.

Indication

Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over. It is also indicated for acne vulgaris in combination with benzoyl peroxide and in a triple combination therapy with benzoyl peroxide and clindamycin.

Associated Conditions

  • Acne Vulgaris

FDA Approved Products

Adapalene
Manufacturer:Taro Pharmaceuticals U.S.A., Inc.
Route:TOPICAL
Strength:3 mg in 1 g
Approved: 2024/02/16
NDC:51672-1377
ADAPALENE AND BENZOYL PEROXIDE
Manufacturer:Alembic Pharmaceuticals Inc.
Route:TOPICAL
Strength:3 mg in 1 g
Approved: 2023/12/11
NDC:62332-662
adapalene and benzoyl peroxide
Manufacturer:Padagis Israel Pharmaceuticals Ltd
Route:TOPICAL
Strength:0.1 g in 100 g
Approved: 2022/10/31
NDC:45802-846
ADAPALENE AND BENZOYL PEROXIDE
Manufacturer:Bryant Ranch Prepack
Route:TOPICAL
Strength:3 mg in 1 g
Approved: 2022/06/02
NDC:63629-9322
Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel Pad
Manufacturer:Gabar Health Sciences Corp.
Route:TOPICAL
Strength:1 mg in 1 g
Approved: 2022/10/06
NDC:82429-012

Singapore Approved Products

DIFFERIN GEL 0.1%
Manufacturer:LABORATOIRES GALDERMA
Form:GEL
Strength:0.1% w/w
Online:Yes
Approved: 1996/10/07
Approval:SIN08957P
DIFACLEAR GEL 0.1%w/w
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:GEL
Strength:1.00mg/g
Online:Yes
Approved: 2016/12/13
Approval:SIN15136P
DIFFERIN CREAM 0.1%
Manufacturer:LABORATOIRES GALDERMA
Form:CREAM
Strength:0.1%
Online:Yes
Approved: 1999/09/16
Approval:SIN11116P
EPIDUO FORTE GEL 0.3%/2.5%
Manufacturer:G PRODUCTION INC, Laboratoires Galderma
Form:GEL
Strength:0.30 %W/W
Online:Yes
Approved: 2018/04/03
Approval:SIN15460P
EPIDUO GEL 0.1%/2.5%
Manufacturer:LABORATOIRES GALDERMA
Form:GEL
Strength:0.10%
Online:Yes
Approved: 2010/04/21
Approval:SIN13789P

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