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Isotretinoin

Generic Name
Isotretinoin
Brand Names
Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane
Drug Type
Small Molecule
Chemical Formula
C20H28O2
CAS Number
4759-48-2
Unique Ingredient Identifier
EH28UP18IF

Overview

Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.

Background

Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.

Indication

Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.

Associated Conditions

  • Acne conglobata
  • Neuroblastoma (NB)
  • Rosacea
  • Sezary Syndrome
  • Early Mycosis Fungoides (MF)
  • Refractory Acne vulgaris
  • Severe Recalcitrant nodular acne

FDA Approved Products

Isotretinoin
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/09/01
NDC:70771-1558
Claravis
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2014/01/20
NDC:54868-6307
Claravis
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2014/01/20
NDC:54868-6308
Claravis
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2014/01/20
NDC:54868-6185
Isotretinoin
Manufacturer:Actavis Pharma, Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2020/09/01
NDC:0591-2451

Singapore Approved Products

ROACCUTANE CAPSULE 20 mg
Manufacturer:Catalent Germany Eberbach GmbH
Form:CAPSULE, LIQUID FILLED
Strength:20 mg
Online:Yes
Approved: 1990/07/10
Approval:SIN04921P
NIMEGEN SOFT CAP. 10 mg
Manufacturer:RP BIO INC.
Form:CAPSULE, LIQUID FILLED
Strength:10 mg
Online:Yes
Approved: 1999/02/23
Approval:SIN10767P
ORATANE CAPSULE 10 mg
Manufacturer:Douglas Manufacturing Ltd, Swiss Caps AG
Form:CAPSULE
Strength:10 mg
Online:Yes
Approved: 2002/01/23
Approval:SIN11782P
ROACCUTANE CAPSULE 10 mg
Manufacturer:F HOFFMANN-LA ROCHE LTD (Primary and Secondary Packaging), Catalent Germany Eberbach GmbH
Form:CAPSULE, LIQUID FILLED
Strength:10 mg
Online:Yes
Approved: 1990/07/10
Approval:SIN04920P
ORATANE CAPSULE 5 mg
Manufacturer:SWISS CAPS AG, Douglas Manufacturing Ltd. (Primary Packaging)
Form:CAPSULE
Strength:5MG
Online:Yes
Approved: 2014/09/22
Approval:SIN14628P

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