Active-ingredient Dossier

Isotretinoin

Active-ingredient Dossier for Isotretinoin (retinoid acne medication). Australian brands, products, PBS listings, PBAC outcomes — compiled by arcimedes.

What is

Isotretinoin Isotretinoin is a retinoid acne medication.

Australian brands containing

Isotretinoin — DERMATANE — ORATANE — ROACCUTANE — ISOTRETINOIN-AS — APO-ISOTRETINOIN — ISOTRETINOIN — ISOTRETINOIN-WGR — PHARMACOR — ISOTRETINOIN ASCENT — ISOTRETINOIN-GA — ISOTRETINOIN-PS

Therapeutic areas

Isotretinoin is registered in Infectious Disease (11 brands) and Dermatology (2 brands).

Sponsor landscape

Isotretinoin is marketed by six sponsors: Arrotex Pharmaceuticals, Southern Cross Pharma, Dr Reddys Laboratories, Strides Pharma Science, GM Pharma, and Pharmaco.

PBS and regulatory activity

Three brands containing isotretinoin have PBS-listed items, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome on record is from 1 November 2019, with two brands having PBAC outcomes recorded and no brands with AusPARs on record.