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BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
Lisdexamfetamine dimesylate capsules is a generic version of Vyvanse. This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun supplying 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.
Important Safety Information includes a Boxed Warning, “CNS stimulants, including lisdexamfetamine dimesylate, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence.” For full prescribing information, see package insert located here.
“Lisdexamfetamine dimesylate is a key ADHD medicine currently in shortage. As the No. 4 U.S. Generics business, we are focused on the most impactful and essential areas of pharmaceuticals. We expect to launch over 30 new medicines in 2023,” said Andrew Boyer, executive vice president, Amneal Generics.
