Amneal Pharmaceuticals has introduced its generic Accutane (isotretinoin) capsules. The drug is indicated to treat severe recalcitrant nodular acne.
Amneal’s generic Accutane was approved under a Risk Evaluation and Mitigation Strategy known as the
iPledge Program.
The product had U.S. sales of roughly $250 million for the 12 months ended December 2017, according to IQVIA data. Amneal’s generic Accutane will be available in 10-, 20-, 30- and 40-mg dosage strengths in cartons that contain three blister packs with 10 capsules each.
Ameal said it would begin shipping the product immediately.