FDA Approves First Generics of ADHD Drug Vyvanse

The FDA has approved the first generics of Takeda’s Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets to treat attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating disorder in adults. Approvals have been given to 15 different manufacturers. The list of these new generics can be found here.

ADHD is one of the most common neurodevelopmental disorders of childhood, affecting about 10% of children, the FDA said in a press release. ADHD can be successfully managed with behavioral and pharmacological treatment, and some symptoms may improve as the child ages. Patients with binge-eating disorder have recurrent episodes of compulsive overeating. Binge eating disorder is the most common eating disorder in the United States, affecting about 1.25% of adult women and 0.42% of adult men, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

Vyvanse was approved by the FDA in 2007 to treat patients with ADHD and in 2015 to treat patients with binge-eating disorder.

Vyvanse has experienced some shortages of some products, including the 60 mg capsules and 70 mg capsules in 100 count bottles, because of a manufacturing delay and increased demand, according to the American Society of Health-System Pharmacists. Takeda has Vyvanse 60 mg and 70 mg capsules on intermittent back order and the company estimates this will continue into September 2023.

In other generic news:

• ANI Pharmaceuticals has received FDA approval for Estradiol Gel, 0.1%, a generic version of Vertical Pharmaceuticals’ Divigel, which is used to treat patients with menopause and hot flashes
• Dr. Reddy’s has launched Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, a therapeutic equivalent generic version of AstraZeneca’s Kombiglyze, which is used to treat patients with type 2 diabetes.
• Hikma Pharmaceuticals has launched Vancomycin hydrochloride for injection in 1.25 g and 1.5 g doses, which treats infections, including septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections due to susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci.