Amneal obtains FDA OK for generic Vyvanse

Amneal has received the Food and Drug Administration’s green light 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.

Amneal noted that this ADHD product is currently on the 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 in patients 6 years and above and for adults with moderate to severe Binge Eating Disorder.

Lisdexamfetamine dimesylatehad a market value of $5.3 billion for the 12 months ended June 2023, per IQVIA.

[Read more: Amneal touts 26 generic new product launches in 2022]

“Lisdexamfetamine dimesylate is a key ADHD medicine currently in shortage. As the #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 of Amneal generics.

[Read more: Amneal debuts 2 generics]