BRIDGEWATER, NJ — Amneal Pharmaceuticals has launched isotretinoin capsules, USP, an AB-rated generic for Accutane used to treat severe recalcitrant nodular acne in 10 mg, 20 mg, 30 mg and 40 mg. The product is available in cartons containing 3 blister packs of 10 capsules each and it began shipping today.
Amneal’s generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the iPledge program. Information on this REMS program is available at https://ipledgeprogram.com or 866-495-0654.
Annual U.S. sales of isotretinoin capsules were $250 million, according to December 2017 IQVIA market data.