Amneal Pharmaceuticals has launched isotretinoin capsules, USP, an AB-rated generic for Accutane in 10 mg, 20 mg, 30 mg and 40 mg strengths. The product is available in cartons containing 3 blister packs of 10 capsules each.
Amneal's generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the iPledge program.
Annual U.S. sales of isotretinoin capsules were $250 million, according to December 2017 IQVIA market data.