The US FDA granted an Abbreviated New Drug Application (ANDA) to Amneal Pharmaceuticals for lisdexamfetamine dimesylate capsules (20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg), generic version of the ADHD medication Vyvanse®.
This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun supplying the product to the market. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and above and for adults with moderate to severe Binge Eating Disorder. According to IQVIA®, U.S. annual sales for lisdexamfetamine dimesylate for the 12 months ended June 2023 were $5.3 billion.